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Powder Free Latex Examination Gloves - EUDAMED Registration 09551003455973

Access comprehensive regulatory information for Powder Free Latex 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 09551003455973 and manufactured by Supermax Glove Manufacturing Sdn Bhd in Malaysia.

This page provides complete registration details including trade name (Sensitive Touch (Non Sterile Powder Free Latex Examination Gloves)), 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
09551003455973
No
Powder Free Latex Examination Gloves
Trade Name: Sensitive Touch (Non Sterile Powder Free Latex Examination Gloves)
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Device Description (EMDN)

LATEX EXAMINATION / TREATMENT GLOVES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T010201
Trade Name
Sensitive Touch (Non Sterile Powder Free Latex Examination Gloves)
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09551003455973
Basic UDI
955100345123B3
Version Date
April 03, 2023
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
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
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No