Pure Global

H. pylori Antibody Rapid Test - EUDAMED Registration 06936983109451

Access comprehensive regulatory information for H. pylori Antibody Rapid Test in the European Union medical device market through Pure Global AI's free database. This Class B device is registered with EU EUDAMED under Primary DI 06936983109451 and manufactured by Hangzhou Alltest Biotech.Co.,Ltd. in China.

This page provides complete registration details including trade name (H. pylori Antibody Rapid Test), manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Münster), 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
Class B
06936983109451
No
H. pylori Antibody Rapid Test
Trade Name: H. pylori Antibody Rapid Test
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Device Description (EMDN)

H. PYLORI - RT & POC

Device Classification
Risk Class
Class B
CND Nomenclatures Code
W0105090102
Trade Name
H. pylori Antibody Rapid Test
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06936983109451
Basic UDI
6970277510000EXK
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
#550 Yinhai Street Hangzhou
Email
info@alltests.com.cn
Authorized Representative
SRN
DE-AR-000000002
Country
Germany
Address
10 Borkstrasse Münster
Email
ecrep@medneteurope.com
Telephone
+49 251 322 66 64
Regulatory Information
Competent Authority
DE/CA22 - Bezirksregierung Münster
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Germany
Market Available
Germany:None~None, Ireland:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
Yes