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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 16:44

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.

Authorised representative SRN

Narrows by the device authorised representative SRN.

Active filter:Manufacturer SRN:CN-MF-000017965

609 device results listed.

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Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRA-545aWP
Basic UDI-DI: B-GCFCRA-545aWP
Reference: GCFCRA-545a
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 Ag Control Kit

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRA-PN27N
Basic UDI-DI: B-GCFCRA-PN27N
Reference: GCFCRA-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

COVID-19/Flu A&B/RSV/Adeno 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-GCFCRA-T525a8X
Basic UDI-DI: B-GCFCRA-T525a8X
Reference: GCFCRA-T525a
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/Flu B/RSV/ADV/M.P 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-GCFCRAMP-T535aDE
Basic UDI-DI: B-GCFCRAMP-T535aDE
Reference: GCFCRAMP-T535a
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

Influenza A Ag Rapid Test Strip (Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(A)-501aWQ
Basic UDI-DI: B-GCFLU(A)-501aWQ
Reference: GCFLU(A)-501a
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

Influenza A & B Ag Rapid Test Strip (Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(A/B)-501aAB
Basic UDI-DI: B-GCFLU(A/B)-501aAB
Reference: GCFLU(A/B)-501a
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

Influenza A & B 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-GCFLU(A/B)-5024L
Basic UDI-DI: B-GCFLU(A/B)-5024L
Reference: GCFLU(A/B)-502a，GCFLU(A/B)-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

Flu A/RSV 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-GCFR(A)-T502aMC
Basic UDI-DI: B-GCFR(A)-T502aMC
Reference: GCFR(A)-T502a
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

Flu A&B/RSV 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-GCFR-T502a4G
Basic UDI-DI: B-GCFR-T502a4G
Reference: GCFR-T502a
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

Giardia lamblia 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-GCGIA-602aT3
Basic UDI-DI: B-GCGIA-602aT3
Reference: GCGIA-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

Gonorrhea Rapid Test Cassette (Swab)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCGON-502b3G
Basic UDI-DI: B-GCGON-502b3G
Reference: GCGON-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

HAV 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-GCHAV(IgG/IgM)-302aL2
Basic UDI-DI: B-GCHAV(IgG/IgM)-302aL2
Reference: GCHAV(IgG/IgM)-302a
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

HAV 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-GCHAV(IgG/IgM)-402aL9
Basic UDI-DI: B-GCHAV(IgG/IgM)-402aL9
Reference: GCHAV(IgG/IgM)-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

HAV 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-GCHAV(IgM)-302BaVF
Basic UDI-DI: B-GCHAV(IgM)-302BaVF
Reference: GCHAV(IgM)-302Ba
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

HAV Ag Rapid Test Cassette (Feces)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHAV-602aXX
Basic UDI-DI: B-GCHAV-602aXX
Reference: GCHAV-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

HEV 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-GCHEV-302aZE
Basic UDI-DI: B-GCHEV-302aZE
Reference: GCHEV-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

H. pylori 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-GCHP-301aYK
Basic UDI-DI: B-GCHP-301aYK
Reference: GCHP-301a
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

H. pylori Ab 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-GCHP-302aYN
Basic UDI-DI: B-GCHP-302aYN
Reference: GCHP-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

H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-401aYS
Basic UDI-DI: B-GCHP-401aYS
Reference: GCHP-401a
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

H. pylori Ab 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-GCHP-402aYV
Basic UDI-DI: B-GCHP-402aYV
Reference: GCHP-402a
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

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