Public EUDAMED Search

EUDAMED Device Search

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

Last updated

01.08.2026 05:11

Sync status

Successful

Device

2988371

Actor

47520

Certificate

3174

Filters

Show filters

Active filter:EMDN:W0102090122

5 device results listed.

Page 1 / 1

One Step Fentanyl Test Cassette (Urine)

GBFEN-102b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

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: W0102090122
EMDN description: FENTANYL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Fentanyl Test Strip (Urine)

GBFEN-101b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

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: W0102090122
EMDN description: FENTANYL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

Fentanyl Rapid Test Kit (Time-Resolved FIA)

FBFEN-102a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FBFEN-102aSW
Basic UDI-DI: B-FBFEN-102aSW
Reference: FBFEN-102a
EMDN: W0102090122
EMDN description: FENTANYL
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Fentanyl Rapid Test Kit (Time-Resolved FIA)

FBFEN-102a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FBFEN-102aHGPE
Basic UDI-DI: B-FBFEN-102aHGPE
Reference: FBFEN-102a
EMDN: W0102090122
EMDN description: FENTANYL
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Fentanyl (FYL) Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303421
Basic UDI-DI: B-06974566303421
Reference: DFY-105
EMDN: W0102090122
EMDN description: FENTANYL
First on market country: Iceland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details