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MEDICAL FACE MASK - EUDAMED Registration 09555987230106

Access comprehensive regulatory information for MEDICAL FACE MASK 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 09555987230106 and manufactured by TOP FEEL SDN. BHD. in Malaysia.

This page provides complete registration details including trade name (TOP MASK), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf 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
09555987230106
No
MEDICAL FACE MASK
Trade Name: TOP MASK
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Device Description (EMDN)

MEDICAL USE FACE MASKS, TYPE II AND IIR

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T020604
Trade Name
TOP MASK
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09555987230106
Basic UDI
955598720000NU
Version Date
January 18, 2023
Manufacturer Last Update
December 23, 2021
Active Status
No
Manufacturer
Manufacturer Name
TOP FEEL SDN. BHD.
Country
Malaysia
Country Type
NON_EU
Address
LOT 5090 JALAN TERATAI, BATU 5, OFF JALAN MERU, SELANGOR DARUL EHSAN
Email
fatimawati@topglove.com.my
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 Düsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No