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Monkeypox Virus IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) - EUDAMED Registration D-WI-MPXV-C42-25L6

Access comprehensive regulatory information for Monkeypox Virus IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) 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-MPXV-C42-25L6 and manufactured by Zhejiang Wantaifu Biotechnology Co., Ltd in China.

This page provides complete registration details including trade name (BioยทFirm), manufacturer information, authorized representative details, competent authority (DE/CA24 - Regierungsprรคsidium 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.

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EUDAMED Official Data
IVD General
D-WI-MPXV-C42-25L6
No
Monkeypox Virus IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)
Trade Name: BioยทFirm
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Device Description (EMDN)

VIROLOGY - RT & POC - OTHER

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0105099099
Trade Name
BioยทFirm
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-WI-MPXV-C42-25L6
Basic UDI
B-WI-MPXV-C42-25L6
Version Date
August 30, 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
ES-AR-000019366
Country
Spain
Address
CALLE DE TAPIOLES, 33, 2- 1 Barcelona
Email
rep@themedunion.com
Telephone
+34644173535
Regulatory Information
Competent Authority
DE/CA24 - Regierungsprรคsidium 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