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EUDAMED

Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

EUDAMED search

Paste UDI code

DataMatrix / UDI quick search

Paste GS1 DataMatrix text or a direct UDI-DI value; the DI value is moved into the search box.

DataMatrix or UDI text

Devices Actors Certificates SSCP Insights Classification Resources

Last updated

25.08.2026 10:02

Sync status

Successful

Device

3108040

Actor

47631

Certificate

3281

This platform is not the official EUDAMED. Data is provided for information only; final verification must be completed through the official EUDAMED system.

Filters

Risk class

Narrows by MDR/IVDR risk level.

Legislation

Select MDR or IVDR scope.

Device status

Filters by EUDAMED device record status.

Country

Filters by actor country code.

Country role

This only applies together with the country filter. Select a country first.

Manufacturer name

Filters by manufacturer name.

Manufacturer SRN

CN-MF-000012852

Manufacturer actor SRN number.

EMDN code

European medical device nomenclature code.

Medical branch

Narrows by clinical area such as neurology, cardiology or orthopaedics.

Authorised representative SRN

Narrows by the device authorised representative SRN.

Show filtersExpand

Risk class

Narrows by MDR/IVDR risk level.

Legislation

Select MDR or IVDR scope.

Device status

Filters by EUDAMED device record status.

Country

Filters by actor country code.

Country role

This only applies together with the country filter. Select a country first.

Manufacturer name

Filters by manufacturer name.

Manufacturer SRN

CN-MF-000012852

Manufacturer actor SRN number.

EMDN code

European medical device nomenclature code.

Medical branch

Narrows by clinical area such as neurology, cardiology or orthopaedics.

Authorised representative SRN

Narrows by the device authorised representative SRN.

Active filter:Manufacturer SRN:CN-MF-000012852

417 device results listed.

Page 15 / 21

Page 15 / 21

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PRL Rapid Quantitative Test (Chemiluminescence Immunoassay)

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IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205646
Basic UDI-DI: B-06933260205646
Reference: BT0503201
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

LH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205639
Basic UDI-DI: B-06933260205639
Reference: BT0503105
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

LH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205622
Basic UDI-DI: B-06933260205622
Reference: BT0503104
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

LH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205615
Basic UDI-DI: B-06933260205615
Reference: BT0503103
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

LH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205608
Basic UDI-DI: B-06933260205608
Reference: BT0503102
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

LH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205592
Basic UDI-DI: B-06933260205592
Reference: BT0503101
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205585
Basic UDI-DI: B-06933260205585
Reference: BT0503005
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205578
Basic UDI-DI: B-06933260205578
Reference: BT0503004
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205561
Basic UDI-DI: B-06933260205561
Reference: BT0503003
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205554
Basic UDI-DI: B-06933260205554
Reference: BT0503002
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205547
Basic UDI-DI: B-06933260205547
Reference: BT0503001
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

TPOAb Rapid Quantitative Test(Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205288
Basic UDI-DI: B-06933260205288
Reference: BT0502405
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

TPOAb Rapid Quantitative Test(Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205271
Basic UDI-DI: B-06933260205271
Reference: BT0502404
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

TPOAb Rapid Quantitative Test(Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205264
Basic UDI-DI: B-06933260205264
Reference: BT0502403
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

TPOAb Rapid Quantitative Test(Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205257
Basic UDI-DI: B-06933260205257
Reference: BT0502402
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

TPOAb Rapid Quantitative Test(Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205240
Basic UDI-DI: B-06933260205240
Reference: BT0502401
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

TGAb Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205233
Basic UDI-DI: B-06933260205233
Reference: BT0502305
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

TGAb Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205226
Basic UDI-DI: B-06933260205226
Reference: BT0502304
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

TGAb Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205219
Basic UDI-DI: B-06933260205219
Reference: BT0502303
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

TGAb Rapid Quantitative Test (Chemiluminescence Immunoassay)

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205202
Basic UDI-DI: B-06933260205202
Reference: BT0502302
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

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