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EUDAMED Device Search

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

Last updated

17.07.2026 03:09

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634 device results listed.

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One Step Multi-Drug Screen Test Cassette (Urine)

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IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDOA-1X5-ALCOGJT
Basic UDI-DI: B-GBDOA-1X5-ALCOGJT
Reference: GBDOA-1X5-ALC
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDUA-1X5-ALCOGRR
Basic UDI-DI: B-GBDUA-1X5-ALCOGRR
Reference: GBDUA-1X5-ALC
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Alcohol Test Strip

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IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBALC-101aOGJY
Basic UDI-DI: B-GBALC-101aOGJY
Reference: GBALC-101a
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDOA-1X5OGUQ
Basic UDI-DI: B-GBDOA-1X5OGUQ
Reference: GBDOA-1X5
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

Premom Pregnancy Test

PMS-150

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-PMS-150Z7
Basic UDI-DI: B-PMS-150Z7
Reference: PMS-150
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Premom Pregnancy Test

PMS-120

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-PMS-120YW
Basic UDI-DI: B-PMS-120YW
Reference: PMS-120
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal pH Rapid Test Strip (Swab)

Vaginal pH Rapid Test Strip (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGVPH-501aLF
Basic UDI-DI: B-OGVPH-501aLF
Reference: VPH-501a
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Total IgE Rapid Test Cassette (Serum/Plasma)

GGIGE-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGGIGE-302aJX
Basic UDI-DI: B-OGGGIGE-302aJX
Reference: GGIGE-302a
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood Rapid Test Strip (Feces)

GEFOB-601b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGEFOB-601bKD
Basic UDI-DI: B-OGGEFOB-601bKD
Reference: GEFOB-601b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood Rapid Test Strip (Feces)

GEFOB-601Cb

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGEFOB-601CbS3
Basic UDI-DI: B-OGGEFOB-601CbS3
Reference: GEFOB-601Cb
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)

GECEA-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGECEA-402aBG
Basic UDI-DI: B-OGGECEA-402aBG
Reference: GECEA-401a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma)

GECEA-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGECEA-401aBD
Basic UDI-DI: B-OGGECEA-401aBD
Reference: GECEA-401a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDTRO-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGDTRO-402bZH
Basic UDI-DI: B-OGGDTRO-402bZH
Reference: GDTRO-402b
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDPCT-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGDPCT-T402aBZ
Basic UDI-DI: B-OGGDPCT-T402aBZ
Reference: GDPCT-T401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Semi-Quantitative Rapid Test Strip (Whole Blood/Serum/Plasma)

GDPCT-T401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGDPCT-T401aBW
Basic UDI-DI: B-OGGDPCT-T401aBW
Reference: GDPCT-T401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Oral Fluid Drug Test Square Cube

GBDSA-XXXXRX

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGBDSA-XXXXRX6H
Basic UDI-DI: B-OGGBDSA-XXXXRX6H
Reference: GBDSA-XXXXRX
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cassette (Urine)

GBDOA-1X5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-OGGBDOA-1X5DN
Basic UDI-DI: B-OGGBDOA-1X5DN
Reference: GBDOA-1X5
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test Cassette (Whole Blood)

GIVD-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIVD-402b76
Basic UDI-DI: B-GIVD-402b76
Reference: GIVD-402b
EMDN: W0102070206
EMDN description: VITAMIN D (CHOLECALCIFEROL)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Rapid Test Cassette (Whole Blood)

GIVD-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIVD-402a74
Basic UDI-DI: B-GIVD-402a74
Reference: GIVD-402a
EMDN: W0102070206
EMDN description: VITAMIN D (CHOLECALCIFEROL)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Microalbumin Test Cassette (Urine)

GIHSA-103a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIHSA-103a4D
Basic UDI-DI: B-GIHSA-103a4D
Reference: GIHSA-103a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details