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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 22:14

Sync status

Successful

Device

2680652

Actor

47323

Certificate

3039

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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One Step Fentanyl Test Strip (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-GBFEN-101bTS
Basic UDI-DI: B-GBFEN-101bTS
Reference: GBFEN-101b
EMDN: -
EMDN description: FENTANYL
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

One Step Fentanyl Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBFEN-102bTV
Basic UDI-DI: B-GBFEN-102bTV
Reference: GBFEN-102b
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

One Step Hydrocodone Test Strip (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBHCD-101aPS
Basic UDI-DI: B-GBHCD-101aPS
Reference: GBHCD-101a
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

One Step Hydrocodone Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBHCD-102aPV
Basic UDI-DI: B-GBHCD-102aPV
Reference: GBHCD-102a
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

One Step K2 Test Strip (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBK2-101aMC
Basic UDI-DI: B-GBK2-101aMC
Reference: GBK2-101a
EMDN: -
EMDN description: CANNABINOIDS
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

One Step K2 Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBK2-102aMF
Basic UDI-DI: B-GBK2-102aMF
Reference: GBK2-102a
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

One Step Ketamine Test Strip (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBKET-101aZ5
Basic UDI-DI: B-GBKET-101aZ5
Reference: GBKET-101a
EMDN: -
EMDN description: DRUGS OF ABUSE - OTHER
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

One Step Ketamine Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBKET-102aZ8
Basic UDI-DI: B-GBKET-102aZ8
Reference: GBKET-102a
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

One Step Kratom Test Strip (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBKRA-101aYB
Basic UDI-DI: B-GBKRA-101aYB
Reference: GBKRA-101a
EMDN: -
EMDN description: DRUGS OF ABUSE - OTHER
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

One Step Kratom Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBKRA-102aYE
Basic UDI-DI: B-GBKRA-102aYE
Reference: GBKRA-102a
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

One Step Lysergic Acid Diethylamide Test Strip (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBLSD-101a2R
Basic UDI-DI: B-GBLSD-101a2R
Reference: GBLSD-101a
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

One Step Lysergic Acid Diethylamide Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBLSD-102a2U
Basic UDI-DI: B-GBLSD-102a2U
Reference: GBLSD-102a
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

One Step 6-MAM Test Strip (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBMAM-S101a27
Basic UDI-DI: B-GBMAM-S101a27
Reference: GBMAM-S101a
EMDN: -
EMDN description: DRUGS OF ABUSE - OTHER
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

One Step 6-MAM Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBMAM-S102a2A
Basic UDI-DI: B-GBMAM-S102a2A
Reference: GBMAM-S102a
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

One Step 3,4-Methylenedioxypyrovalerone Test Strip (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBMDP-101aY6
Basic UDI-DI: B-GBMDP-101aY6
Reference: GBMDP-101a
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

One Step 3,4-Methylenedioxypyrovalerone Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBMDP-102aY9
Basic UDI-DI: B-GBMDP-102aY9
Reference: GBMDP-102a
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

One Step Methylphenidate Test Strip (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBMPD-101aZN
Basic UDI-DI: B-GBMPD-101aZN
Reference: GBMPD-101a
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

One Step Methylphenidate Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBMPD-102aZR
Basic UDI-DI: B-GBMPD-102aZR
Reference: GBMPD-102a
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

One Step Methaqualone Test Strip (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBMQL-101a5J
Basic UDI-DI: B-GBMQL-101a5J
Reference: GBMQL-101a
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

One Step Methaqualone Test Cassette (Urine)

-

IVD generalNot specifiedOn the market

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBMQL-102a5M
Basic UDI-DI: B-GBMQL-102a5M
Reference: GBMQL-102a
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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