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EUDAMED Device Search

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436 device results listed.

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VivaDiag™ MDPHP Rapid Test

VDMDP-A101

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMDP-A101FZ
Basic UDI-DI: B-VDMDP-A101FZ
Reference: VDMDP-A101
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

Panel: 25 test/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-THC-05-25tMS
Basic UDI-DI: B-THC-05-25tMS
Reference: THC-05-25t
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

THC-02-25t

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-THC-02-25tLR
Basic UDI-DI: B-THC-02-25tLR
Reference: THC-02-25t
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

THC-01-100t

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-THC-01-100t8S
Basic UDI-DI: B-THC-01-100t8S
Reference: THC-01-100t
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

Panel: 25 test/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-TCA-05-25tGZ
Basic UDI-DI: B-TCA-05-25tGZ
Reference: TCA-05-25t
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

Cassette: 25 test/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-TCA-02-25tFY
Basic UDI-DI: B-TCA-02-25tFY
Reference: TCA-02-25t
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

Strip: 100 test/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-TCA-01-100t2T
Basic UDI-DI: B-TCA-01-100t2T
Reference: TCA-01-100t
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 10:55

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

Hair Multi-Drug Rapid Test Kit (ICA)

GBXXX-1102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBXXX-1102J6
Basic UDI-DI: B-GBXXX-1102J6
Reference: GBXXX-1102
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Drugs of Abuse Test Dip Card (Urine)

GBXXX-105

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBXXX-105NM
Basic UDI-DI: B-GBXXX-105NM
Reference: GBXXX-105
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Drugs of Abuse Test Cassette (Urine)

GBXXX-102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBXXX-102NF
Basic UDI-DI: B-GBXXX-102NF
Reference: GBXXX-102
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Drugs of Abuse Test Strip (Urine)

GBXXX-101

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBXXX-101ND
Basic UDI-DI: B-GBXXX-101ND
Reference: GBXXX-101
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step UR-144 Test Cassette (Urine)

GBUR-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBUR-102a7F
Basic UDI-DI: B-GBUR-102a7F
Reference: GBUR-102a
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step UR-144 Test Strip (Urine)

GBUR-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBUR-101a7C
Basic UDI-DI: B-GBUR-101a7C
Reference: GBUR-101a
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Tramadol Test Cassette (Urine)

GBTRA-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBTRA-102a5U
Basic UDI-DI: B-GBTRA-102a5U
Reference: GBTRA-102a
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Tramadol Test Strip (Urine)

GBTRA-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBTRA-101a5R
Basic UDI-DI: B-GBTRA-101a5R
Reference: GBTRA-101a
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 00:20

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Tricyclic Antidepressants Test Cassette (Urine)

GBTCA-102a

IVD generalIVDDOn the marketAnimal tissuesKitSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBTCA-102aVS
Basic UDI-DI: B-GBTCA-102aVS
Reference: GBTCA-102a
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 00:20

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Tricyclic Antidepressants Test Strip (Urine)

GBTCA-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBTCA-101aVP
Basic UDI-DI: B-GBTCA-101aVP
Reference: GBTCA-101a
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 00:20

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Propoxyphene Test Cassette (Urine)

GBPPX-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBPPX-102aBR
Basic UDI-DI: B-GBPPX-102aBR
Reference: GBPPX-102a
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 00:20

Manufacturer products Authorised representative products Authorised representative actors View details