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EUDAMED registration D-6909620WHDUSBUPM6SJNo

Drugs of Abuse Tests (Buprenorphine)

W.H.P.M. Bioresearch & Technology Co., Ltd.IVD devices for self-testingEU EUDAMEDTrade name: One-Step Drug Of Abuse Test -Buprenorphine (BUP)
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD devices for self-testing
CND nomenclatures code
W0102160599
Trade name
One-Step Drug Of Abuse Test -Buprenorphine (BUP)
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
D-6909620WHDUSBUPM6SJ
Basic UDI
B-6909620WHDUSBUPM6SJ
Version date
March 13, 2023
Manufacturer last update
September 07, 2022
Active status
No
Manufacturer
Manufacturer name
W.H.P.M. Bioresearch & Technology Co., Ltd.
Country
China
Country type
NON_EU
Address
No.2 Zhongxin Street, Louzizhuang, Jinzhanxiang, Chaoyang District Beijing
Email
customerservice@whpm.com.cn
Authorized representative
Name
MDSS GmbH
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed on the market
Germany
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER

About this record

Access comprehensive regulatory information for Drugs of Abuse Tests (Buprenorphine) in the European Union medical device market through Pure Global AI's free database. This IVD devices for self-testing device is registered with EU EUDAMED under Primary DI D-6909620WHDUSBUPM6SJ and manufactured by W.H.P.M. Bioresearch & Technology Co., Ltd. in China.

This page provides complete registration details including trade name (One-Step Drug Of Abuse Test -Buprenorphine (BUP)), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.