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Sperm SP10 protein detection device - EUDAMED Registration D-WW-SP-C91-25LK

Access comprehensive regulatory information for Sperm SP10 protein detection device 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-WW-SP-C91-25LK 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.

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EUDAMED Official Data
IVD General
D-WW-SP-C91-25LK
No
Sperm SP10 protein detection device
Trade Name: Bio·Firm
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Device Description (EMDN)

FERTILITY/PREGNANCY RT & POC - OTHER

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0102160399
Trade Name
Bio·Firm
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-WW-SP-C91-25LK
Basic UDI
B-WW-SP-C91-25LK
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
ES-AR-000000293
Country
Spain
Address
C/ Horacio Lengo N18 Málaga
Email
info@cmcmedicaldevices.com
Telephone
+34951214054
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