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Malaria Pf (HRP2) Ag Rapid Test Kit - EUDAMED Registration D-SC20102W-50TVS

Access comprehensive regulatory information for Malaria Pf (HRP2) Ag Rapid Test Kit 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-SC20102W-50TVS and manufactured by Jiangsu Bioperfectus Technologies Co., Ltd. in China.

This page provides complete registration details including trade name (Malaria Pf (HRP2) Ag Rapid Test Kit), manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Mรผnster), 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-SC20102W-50TVS
No
Malaria Pf (HRP2) Ag Rapid Test Kit
Trade Name: Malaria Pf (HRP2) Ag Rapid Test Kit
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Device Description (EMDN)

PLASMODIUM (MALARIA) - RT & POC

Device Classification
Risk Class
IVD General
CND Nomenclatures Code
W0105090401
Trade Name
Malaria Pf (HRP2) Ag Rapid Test Kit
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
D-SC20102W-50TVS
Basic UDI
B-SC20102W-50TVS
Version Date
August 14, 2023
Manufacturer Last Update
August 03, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No. 837, Yaocheng Avenue, 225300 Taizhou City, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA. Taizhou,Jiangsu
Email
support@bioperfectus.com
Authorized Representative
SRN
DE-AR-000000002
Country
Germany
Address
10 Borkstrasse Mรผnster
Email
ecrep@medneteurope.com
Telephone
+49 251 322 66 64
Regulatory Information
Competent Authority
DE/CA22 - Bezirksregierung Mรผnster
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
Yes