Pure Global

Gonorrhea Rapid Test - EUDAMED Registration D-WI-GON-C71-25FZ

Access comprehensive regulatory information for Gonorrhea Rapid Test in the European Union medical device market through Pure Global AI's free database. This IVD General device is registered with EU EUDAMED under Primary DI D-WI-GON-C71-25FZ and manufactured by Zhejiang Wantaifu Biotechnology Co., Ltd in China.

This page provides complete registration details including trade name (Bio·Firm), manufacturer information, authorized representative details, competent authority (DE/CA24 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
IVD General
D-WI-GON-C71-25FZ
No
Gonorrhea Rapid Test
Trade Name: Bio·Firm
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

BACTERIOLOGY - RT & POC - OTHER

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0105090199
Trade Name
Bio·Firm
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-WI-GON-C71-25FZ
Basic UDI
B-WI-GON-C71-25FZ
Version Date
October 13, 2024
Manufacturer Last Update
May 08, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.93 Chunchao Road Hangzhou
Email
wtfsw@wontaifull.com
Authorized Representative
SRN
DE-AR-000023626
Country
Germany
Address
18 Friedlebenstraße Frankfurt am Main
Email
info@osenn.de
Regulatory Information
Competent Authority
DE/CA24 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed On The Market
Spain
Device Characteristics
Human Tissues
No
Animal Tissues
Yes