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39 device results listed.

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Emit II Plus Buprenorphine Assay

IVDR_67_GLA_DUB-C_B_REAG_Buprenorphine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601106
Basic UDI-DI: 0405686901069VE
Reference: 10720046
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Buprenorphine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601120
Basic UDI-DI: 0405686901069VE
Reference: 10720048
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Buprenorphine Assay

IVDR_67_GLA_DUB-C_B_REAG_Buprenorphine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601113
Basic UDI-DI: 0405686901069VE
Reference: 10720047
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine Enzyme Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008018
Basic UDI-DI: 0850624008EIABUP02C9
Reference: 08362955190
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: France
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

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

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-BUP-05-25tNJ
Basic UDI-DI: B-BUP-05-25tNJ
Reference: BUP-05-25t
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 03:29

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-BUP-02-25tMH
Basic UDI-DI: B-BUP-02-25tMH
Reference: BUP-02-25t
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 03:29

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-BUP-01-100tCG
Basic UDI-DI: B-BUP-01-100tCG
Reference: BUP-01-100t
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 03:29

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine+Norbuprenorphine Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555623904
Basic UDI-DI: B-08683555623904
Reference: B80317
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:54

Manufacturer products View details

DrugFor™Buprenorphine (BUP) Rapid Test Kit (Urine)

VDDOA10

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548251589
Basic UDI-DI: B-08683548251589
Reference: VDDOA10
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:12

Manufacturer products View details

RapidFor™ Buprenorphine (BUP) Rapid Test Kit (Urine)

VDOA10

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548251299
Basic UDI-DI: B-08683548251299
Reference: VDOA10
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:11

Manufacturer products View details

Buprenorph (BUP) Assay Reagent Kit (CMIA)

C2KG008

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753478509
Basic UDI-DI: B-06976753478509
Reference: C2KG008
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine (BUP) Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Tongzhou Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000038774
UDI-DI: 06975156256882
Basic UDI-DI: B-06975156256882
Reference: D004-1001
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Ireland
Authorised representative: VidaQuick Biotech S.L.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine (BUP) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620919
Basic UDI-DI: B-06974854620919
Reference: P22041
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine (BUP) Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303605
Basic UDI-DI: B-06974566303605
Reference: DBU-105
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Czechia
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

BUP Rapid Test Kit (Colloidal gold method)

DP013

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473307024
Basic UDI-DI: B-06974473307024
Reference: DP013
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorph (BUP) Assay Reagent Kit (CMIA)

C2KN008

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792052819
Basic UDI-DI: B-06971792052819
Reference: C2KN008
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:54

Manufacturer products Authorised representative products Authorised representative actors View details

00884883011670

10015658

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883011670
Basic UDI-DI: B-00884883011670
Reference: 10015658
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

00884883006065

10021390

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883006065
Basic UDI-DI: B-00884883006065
Reference: 10021390
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details