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Powdered Latex Surgical Gloves - EUDAMED Registration 09551003452156

Access comprehensive regulatory information for Powdered Latex Surgical Gloves 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 09551003452156 and manufactured by Supermax Glove Manufacturing Sdn Bhd in Malaysia.

This page provides complete registration details including trade name (KING), 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 IIa
09551003452156
No
Powdered Latex Surgical Gloves
Trade Name: KING
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Device Description (EMDN)

POWDERED LATEX SURGICAL GLOVES

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
T01010101
Trade Name
KING
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09551003452156
Basic UDI
955100345125B7
Version Date
February 19, 2025
Manufacturer Last Update
November 17, 2021
Active Status
No
Manufacturer
Country
Malaysia
Country Type
NON_EU
Address
Lot 38, PUTRA INDUSTRIAL PARK, SUNGAI BULOH, SELANGOR
Email
info@supermax.com.my
Authorized Representative
SRN
BE-AR-000000106
Country
Belgium
Address
53 Boulevard Gรฉnรฉral Wahis Brussels
Email
regulatory@obelis.net
Telephone
+32(2)73 25 954
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
Portugal
Market Available
Portugal:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No