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HOKAPI™ AE-200 - EUDAMED Registration 06939716402430

Access comprehensive regulatory information for HOKAPI™ AE-200 in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06939716402430 and manufactured by Suzhou Hokapi Biomedical Engineering Co., Ltd.. in China.

This page provides complete registration details including trade name (HOKAPI™ AE-200), manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), 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 A
06939716402430
No
HOKAPI™ AE-200
Trade Name: HOKAPI™ AE-200
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Device Description (EMDN)

AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0201020102
Trade Name
HOKAPI™ AE-200
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06939716402430
Basic UDI
69397164AE200LV
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
Building 4, No.8, Jinfeng Road, Science & Technology Park, High Tech New District Suzhou
Email
zhuzhenrong@hybiome.com
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 Eiffestraße Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
Competent Authority
DE/CA05 - Behorde fur Justiz und Verbraucherschutz
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No