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EUDAMED registration 19551017626465No

Nitrile Examination Gloves

Hartalega NGC Sdn. Bhd.Class IEU EUDAMEDTrade name: EMDAMED SOFT TOUCH
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
T01020204
Trade name
EMDAMED SOFT TOUCH
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
19551017626465
Basic UDI
955100777HNGCTFMD005AQ8
Version date
March 07, 2025
Manufacturer last update
May 11, 2022
Active status
No
Manufacturer
Manufacturer name
Hartalega NGC Sdn. Bhd.
Country
Malaysia
Country type
NON_EU
Address
No.1, Persiaran Tanjung, Selangor Darul Ehsan
Email
wkkong@hartalega.com.my
Authorized representative
Name
MDSS GmbH
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory information
Competent authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Netherlands
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

NITRILE EXAMINATION / TREATMENT GLOVES

About this record

Access comprehensive regulatory information for 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 19551017626465 and manufactured by Hartalega NGC Sdn. Bhd. in Malaysia.

This page provides complete registration details including trade name (EMDAMED SOFT TOUCH ), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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.