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EUDAMED registration 16931918152547No

Isolation Gown

GRI Medical & Electronic Technology Co., Ltd.Class IEU EUDAMED
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
T0205
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
16931918152547
Basic UDI
69319181F046L9
Version date
October 06, 2022
Manufacturer last update
January 04, 2022
Active status
No
Manufacturer
Manufacturer name
GRI Medical & Electronic Technology Co., Ltd.
Country
China
Country type
NON_EU
Address
1805 Honggao Road jiaxing
Email
sidonia_dong@gri-china.com
Authorized representative
Name
GRI-Alleset Limited B.V.
SRN
NL-AR-000006457
Country
Netherlands
Address
151 Kingsfordweg Amsterdam
Email
bjenkins@alleset.com
Telephone
678.862.6796
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Netherlands
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)

About this record

Access comprehensive regulatory information for Isolation Gown 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 16931918152547 and manufactured by GRI Medical & Electronic 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.