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Nitrile Examination Gloves - EUDAMED Registration 04046955140701

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 04046955140701 and manufactured by Hartalega Sdn. Bhd. in Malaysia.

This page provides complete registration details including trade name (VASCO GUARD LONG), 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.

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EUDAMED Official Data
Class I
04046955140701
No
Nitrile Examination Gloves
Trade Name: VASCO GUARD LONG
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Device Description (EMDN)

NITRILE EXAMINATION / TREATMENT GLOVES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T01020204
Trade Name
VASCO GUARD LONG
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04046955140701
Basic UDI
955524480HSBTFMD002A5A
Version Date
December 22, 2022
Manufacturer Last Update
July 23, 2021
Active Status
No
Manufacturer
Manufacturer Name
Hartalega Sdn. Bhd.
Country
Malaysia
Country Type
NON_EU
Address
C-G-9, Jalan Dataran SD1 Kuala Lumpur
Email
wkkong@hartalega.com.my
Authorized Representative
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
Germany
Market Available
Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Spain:None~None, Turkey:None~None, Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Czech Republic:None~None, Estonia:None~None, France:None~None, Germany:None~None, Hungary:None~None, Italy:None~None, Latvia:None~None, Lithuania:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No