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EUDAMED Device Search

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

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25.09.2026 03:10

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1000+ device results listed.

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Multi-Drug Rapid Screen Test Cassette (Oral Fluid)

GBDSA-XXXXA/B/G/H/I

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDSA-XXXXA/B/G/H/IFW
Basic UDI-DI: B-GBDSA-XXXXA/B/G/H/IFW
Reference: GBDSA-XXXXA/B/G/H/I
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 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Vacuum Cup (Urine)

GBDOAVC-1X6

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDOAVC-1X68X
Basic UDI-DI: B-GBDOAVC-1X68X
Reference: GBDOAVC-1X6
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 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Key Cup (Urine)

GBDOAA-1X6

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDOAA-1X6ZM
Basic UDI-DI: B-GBDOAA-1X6ZM
Reference: GBDOAA-1X6
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 00:16

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cup (Urine)

GBDOA-1X6

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDOA-1X646
Basic UDI-DI: B-GBDOA-1X646
Reference: GBDOA-1X6
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 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Dip Card (Urine)

GBDOA-1X4

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDOA-1X442
Basic UDI-DI: B-GBDOA-1X442
Reference: GBDOA-1X4
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 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

Drugs of Abuse Rapid Test Cassette(Hair)

GBDOA-11X5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDOA-11X5TW
Basic UDI-DI: B-GBDOA-11X5TW
Reference: GBDOA-11X5
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 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Cotinine Test Cassette (Urine)

GBCOT-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBCOT-102aZS
Basic UDI-DI: B-GBCOT-102aZS
Reference: GBCOT-102a
EMDN: W0102090108
EMDN description: COTININE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Buprenorphine Test Cassette (Urine)

GBBUP-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBBUP-102a2U
Basic UDI-DI: B-GBBUP-102a2U
Reference: GBBUP-102a
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Buprenorphine Test Strip (Urine)

GBBUP-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBBUP-101a2R
Basic UDI-DI: B-GBBUP-101a2R
Reference: GBBUP-101a
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Alcohol Test Dip Card

GBALC-105a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBALC-105aQD
Basic UDI-DI: B-GBALC-105aQD
Reference: GBALC-105a
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 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Alcohol Test Strip

GBALC-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBALC-101aPZ
Basic UDI-DI: B-GBALC-101aPZ
Reference: GBALC-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 00:15

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Phencyclidine Assay

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001963
Basic UDI-DI: 0405686901158VE
Reference: 10445443
EMDN: W0102090114
EMDN description: PHENCYCLIDINE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Propoxyphene Assay

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001925
Basic UDI-DI: 0405686901169VK
Reference: 10445435
EMDN: W0102090115
EMDN description: PROPOXYPHENE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Opiate Assay

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001826
Basic UDI-DI: 0405686901152V2
Reference: 10445417
EMDN: W0102090113
EMDN description: OPIATES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Propoxyphene Assay

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014383
Basic UDI-DI: 0405686901169VK
Reference: 10445434
EMDN: W0102090115
EMDN description: PROPOXYPHENE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Opiate Assay

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014338
Basic UDI-DI: 0405686901152V2
Reference: 10445414
EMDN: W0102090113
EMDN description: OPIATES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Phencyclidine Assay

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014406
Basic UDI-DI: 0405686901158VE
Reference: 10445442
EMDN: W0102090114
EMDN description: PHENCYCLIDINE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

ELISA Ricine eZYDIAG®

ELISA Ricine eZYDIAG®

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Laboratoire Aguettant
Manufacturer SRN: FR-MF-000000509
UDI-DI: D-FRMF-000000509-RicineUC
Basic UDI-DI: B-FRMF-000000509-RicineUC
Reference: ELISA Ricine eZYDIAG®
EMDN: W0102090299
EMDN description: TOXICOLOGY - OTHER
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 21:43

Manufacturer products 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