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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 Resources

Last updated

06.07.2026 15:14

Sync status

Successful

Device

2680564

Actor

47323

Certificate

3038

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

Applies country matching through manufacturer, authorised representative or both roles.

Manufacturer name

Filters by manufacturer name.

Manufacturer SRN

CN-MF-000017965

Manufacturer actor SRN number.

EMDN code

European medical device nomenclature code.

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

Applies country matching through manufacturer, authorised representative or both roles.

Manufacturer name

Filters by manufacturer name.

Manufacturer SRN

CN-MF-000017965

Manufacturer actor SRN number.

EMDN code

European medical device nomenclature code.

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Narrows by the device authorised representative SRN.

Active filter:Manufacturer SRN:CN-MF-000017965

609 device results listed.

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Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma)

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IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMAL(pf/pvAb)-402aAB
Basic UDI-DI: B-GCMAL(pf/pvAb)-402aAB
Reference: GCMAL(pf/pv Ab)-402a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMKP-402a5F
Basic UDI-DI: B-GCMKP-402a5F
Reference: GCMKP-402a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Ag Rapid Test Cassette (Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMKP-502b5Q
Basic UDI-DI: B-GCMKP-502b5Q
Reference: GCMKP-502b
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/IgM Rapid Test Cassette (Serum/Plasma)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMON-325a75
Basic UDI-DI: B-GCMON-325a75
Reference: GCMON-325a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMON-402a6R
Basic UDI-DI: B-GCMON-402a6R
Reference: GCMON-402a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMON-425a7C
Basic UDI-DI: B-GCMON-425a7C
Reference: GCMON-425a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

M. pneumonia IgM Rapid Test Cassette (Serum/Plasma)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMP(IgM)-302aVL
Basic UDI-DI: B-GCMP(IgM)-302aVL
Reference: GCMP(IgM)-302a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

M. pneumoniae Ag Rapid Test Cassette (Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCMP-502a3U
Basic UDI-DI: B-GCMP-502a3U
Reference: GCMP-502a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus Antigen Rapid Test Cassette (Feces)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCNOR-602a9E
Basic UDI-DI: B-GCNOR-602a9E
Reference: GCNOR-602a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cassette (Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCRESA-T555aNB
Basic UDI-DI: B-GCRESA-T555aNB
Reference: GCRESA-T555a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCROA/ADE-602aRF
Basic UDI-DI: B-GCROA/ADE-602aRF
Reference: GCROA/ADE-602a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus and Adenovirus Antigen Control Kit

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCROA/ADE-PN2QK
Basic UDI-DI: B-GCROA/ADE-PN2QK
Reference: GCROA/ADE-PN2
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Control Kit

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCRSV-PNVK
Basic UDI-DI: B-GCRSV-PNVK
Reference: GCRSV-PN2，GCRSV-PN10
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

S. typhi Ag Rapid Test Cassette (Serum/Plasma/Feces)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSAL(ST)-602aS7
Basic UDI-DI: B-GCSAL(ST)-602aS7
Reference: GCSAL(ST)-602a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Strip (Throat Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-501CaCW
Basic UDI-DI: B-GCSTR-501CaCW
Reference: GCSTR-501Ca
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Strip (Throat Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-501CSaJE
Basic UDI-DI: B-GCSTR-501CSaJE
Reference: GCSTR-501CSa
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette (Throat Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-502CaD3
Basic UDI-DI: B-GCSTR-502CaD3
Reference: GCSTR-502Ca
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette (Throat Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-502CSaJM
Basic UDI-DI: B-GCSTR-502CSaJM
Reference: GCSTR-502CSa
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Antigen Control Kit

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-PN2Q4
Basic UDI-DI: B-GCSTR-PN2Q4
Reference: GCSTR-PN2
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Rapid Test Strip (Serum/Plasma)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSYP-301aG5
Basic UDI-DI: B-GCSYP-301aG5
Reference: GCSYP-301a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 02:00

Manufacturer products Authorised representative products Authorised representative actors View details

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