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EUDAMED registration 06939716400177No

HOKAPI™ SARS-COV-2 NEUTRALIZING AB

Suzhou Hokapi Biomedical Engineering Co., Ltd..IVD GeneralEU EUDAMEDTrade name: HOKAPI™ SARS-COV-2 NEUTRALIZING AB
VerifiedEUDAMED · official EU database
Device classification
Risk class
IVD General
CND nomenclatures code
W0105040619
Trade name
HOKAPI™ SARS-COV-2 NEUTRALIZING AB
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06939716400177
Basic UDI
B-06939716400177
Version date
September 01, 2022
Manufacturer last update
November 08, 2021
Active status
No
Manufacturer
Manufacturer name
Suzhou Hokapi Biomedical Engineering Co., Ltd..
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
Name
Shanghai International Holding Corp. GmbH(Europe)
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
IVDD (Directive 98/79/EC on in vitro Diagnostic Medical Devices)
Placed on the market
France
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

CORONAVIRUS

About this record

Access comprehensive regulatory information for HOKAPI™ SARS-COV-2 NEUTRALIZING AB 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 06939716400177 and manufactured by Suzhou Hokapi Biomedical Engineering Co., Ltd.. in China.

This page provides complete registration details including trade name (HOKAPI™ SARS-COV-2 NEUTRALIZING AB), 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.