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Powder Free Nitrile Examination Gloves - EUDAMED Registration 09555586002692

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 09555586002692 and manufactured by Maxwell Glove Manufacturing Berhad in Malaysia.

This page provides complete registration details including trade name (SuperGuard ( Black Nitrile )), 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
09555586002692
No
Powder Free Nitrile Examination Gloves
Trade Name: SuperGuard ( Black Nitrile )
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Device Description (EMDN)

NITRILE EXAMINATION / TREATMENT GLOVES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T01020204
Trade Name
SuperGuard ( Black Nitrile )
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09555586002692
Basic UDI
955558600248LK
Version Date
January 20, 2022
Manufacturer Last Update
November 17, 2021
Active Status
No
Manufacturer
Country
Malaysia
Country Type
NON_EU
Address
Plot 116 & 117, Jalan Logam 7 Kamunting, Perak
Email
info@maxwell.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
Ireland
Market Available
Greece:None~None, Ireland:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No