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Sterile Latex Surgical Powdered Glove - EUDAMED Registration 09555839947671

Access comprehensive regulatory information for Sterile Latex Surgical Powdered Glove in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 09555839947671 and manufactured by TG MEDICAL SDN. BHD. in Malaysia.

This page provides complete registration details including trade name (Top Glove), 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 IIa
09555839947671
No
Sterile Latex Surgical Powdered Glove
Trade Name: Top Glove
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Device Description (EMDN)

POWDERED LATEX SURGICAL GLOVES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
T01010101
Trade Name
Top Glove
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09555839947671
Basic UDI
955583990760QG
Version Date
February 27, 2025
Manufacturer Last Update
July 13, 2021
Active Status
No
Manufacturer
Manufacturer Name
TG MEDICAL SDN. BHD.
Country
Malaysia
Country Type
NON_EU
Address
LOT 5091 JALAN TERATAI, BATU 5, OFF JALAN MERU KLANG
Email
poststelle@bezreg-duesseldorf.nrw.de
Authorized Representative
SRN
DE-AR-000004968
Country
Germany
Address
80 a Bliersheimer Str. Duisburg
Email
info@topglove.de
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:2024-09-30~2029-09-30
Device Characteristics
Human Tissues
No
Animal Tissues
No