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EUDAMED registration 06973589091759No

MINI HOT OR COLD GEL PACK, SQUARE

Wuhan Pakcare Bio‐technology Co.,Ltd.Class IEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
M9001
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06973589091759
Basic UDI
B-06973589091759
Version date
March 21, 2024
Manufacturer last update
January 05, 2023
Active status
No
Manufacturer
Manufacturer name
Wuhan Pakcare Bio‐technology Co.,Ltd.
Country
China
Country type
NON_EU
Address
No. 28-1, Linkong North Road, Hengdian Street, Huangpi district, Wuhan city
Email
alan@pakcare.com
Authorized representative
Name
Share info GmbH
SRN
DE-AR-000005132
Country
Germany
Address
83 Heerdter Lohweg Düsseldorf
Email
eu-rep@share-info.com
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Germany
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

CRYOTHERAPY AND THERMOTHERAPY DEVICES

About this record

Access comprehensive regulatory information for MINI HOT OR COLD GEL PACK, SQUARE in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 06973589091759 and manufactured by Wuhan Pakcare Bio‐technology Co.,Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.