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Nitrile Examination Gloves - EUDAMED Registration 89385507017698

Access comprehensive regulatory information for Nitrile Examination Gloves 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 89385507017698 and manufactured by Ecoglove Medical Manufacturing Company Limited in Vietnam.

This page provides complete registration details including trade name (ECOGLOVE), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24), 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 I
89385507017698
No
Nitrile Examination Gloves
Trade Name: ECOGLOVE
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Device Description (EMDN)

NITRILE EXAMINATION / TREATMENT GLOVES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T01020204
Trade Name
ECOGLOVE
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
89385507017698
Basic UDI
0850053402GANGNITRILE01HG
Version Date
June 26, 2023
Manufacturer Last Update
December 30, 2022
Active Status
No
Manufacturer
Country
Vietnam
Country Type
NON_EU
Address
N4 Street A part of land plot No.679, Map No 41, Bau Bang District
Email
info@ecogloves.vn
Authorized Representative
SRN
DE-AR-000004974
Country
Germany
Address
97 Alsstr. Mรถnchengladbach
Email
joe@europecert.eu
Telephone
+49 2161 990 88 31
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Device Characteristics
Human Tissues
No
Animal Tissues
No