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417 device results listed.

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LH Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208449
Basic UDI-DI: B-06933260208449
Reference: BT2206
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208432
Basic UDI-DI: B-06933260208432
Reference: BT2205
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

TSH Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208425
Basic UDI-DI: B-06933260208425
Reference: BT2204
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

PROG Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208418
Basic UDI-DI: B-06933260208418
Reference: BT2203
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208401
Basic UDI-DI: B-06933260208401
Reference: BT2202
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

hFABP Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208395
Basic UDI-DI: B-06933260208395
Reference: BT2108
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/CK-MB/Myo/D-Dimer/NT-proBNP Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208388
Basic UDI-DI: B-06933260208388
Reference: BT2107
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208371
Basic UDI-DI: B-06933260208371
Reference: BT2106
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208364
Basic UDI-DI: B-06933260208364
Reference: BT2105
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/CK-MB/Myo Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208357
Basic UDI-DI: B-06933260208357
Reference: BT2104
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Quantitative Test

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208340
Basic UDI-DI: B-06933260208340
Reference: BT2103
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

Myo Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208333
Basic UDI-DI: B-06933260208333
Reference: BT2102
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Rapid Quantitative Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208326
Basic UDI-DI: B-06933260208326
Reference: BT2101
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

HbAlc 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: 06933260208302
Basic UDI-DI: B-06933260208302
Reference: BT0507505
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

HbAlc 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: 06933260208296
Basic UDI-DI: B-06933260208296
Reference: BT0507504
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

HbAlc 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: 06933260208289
Basic UDI-DI: B-06933260208289
Reference: BT0507503
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

HbAlc 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: 06933260208272
Basic UDI-DI: B-06933260208272
Reference: BT0507502
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

HbAlc 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: 06933260208265
Basic UDI-DI: B-06933260208265
Reference: BT0507501
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

Phencyclidine （PCP） Rapid Test（Urine）

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208203
Basic UDI-DI: B-06933260208203
Reference: BT0105301
EMDN: W0102160509
EMDN description: PHENCYCLIDINE - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

K2 Rapid Test（Urine）

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208197
Basic UDI-DI: B-06933260208197
Reference: BT0105201
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 10:59

Manufacturer products Authorised representative products Authorised representative actors View details