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Powder Free Nitrile Examination Gloves - EUDAMED Registration 09555586001886

Access comprehensive regulatory information for Powder Free 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 09555586001886 and manufactured by Maxter Glove Manufacturing Sdn Bhd in Malaysia.

This page provides complete registration details including trade name (MAXCHAMP), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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
09555586001886
No
Powder Free Nitrile Examination Gloves
Trade Name: MAXCHAMP
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Device Description (EMDN)

NITRILE EXAMINATION / TREATMENT GLOVES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T01020204
Trade Name
MAXCHAMP
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09555586001886
Basic UDI
955500211638CT
Version Date
January 23, 2025
Manufacturer Last Update
November 17, 2021
Active Status
No
Manufacturer
Country
Malaysia
Country Type
NON_EU
Address
Lot 6070, Jalan Haji Abdul Manan Klang, Selangor
Email
info@maxter.com.my
Authorized Representative
SRN
IE-AR-000013888
Country
Ireland
Address
38 Main Street Swords, County Dublin
Email
sales@supermax.co.uk
Telephone
+44 1733 615215
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Romania
Device Characteristics
Human Tissues
No
Animal Tissues
No