Pure Global
09551025720042

Nitrile Powder Free Examination Gloves

ONETEXX SDN.BHD.·Class I·EU EUDAMED·Trade name: ÖSTERREICHISCHE ROTEN KREUZNo
Device classification
Risk class
Class I
CND nomenclatures code
T01020204
Trade name
ÖSTERREICHISCHE ROTEN KREUZ
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
09551025720042
Basic UDI
95541005249035PFNPEGK4
Version date
November 27, 2024
Manufacturer last update
October 07, 2022
Active status
No
Manufacturer
Manufacturer name
ONETEXX SDN.BHD.
Country
Malaysia
Country type
NON_EU
Address
Perindustrian Kamunting 3 Lot 73-86, Jalan Logam 5, Kamunting
Email
freddylow@oneglovegroup.com
Authorized representative
Name
Europecert UG (haftungsbeschränkt)
SRN
DE-AR-000004974
Country
Germany
Address
97 Alsstr. Mönchengladbach
Email
joe@europecert.eu
Telephone
+49 2161 990 88 31
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Germany
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

NITRILE EXAMINATION / TREATMENT GLOVES

About this record

Access comprehensive regulatory information for Nitrile Powder Free 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 09551025720042 and manufactured by ONETEXX SDN.BHD. in Malaysia.

This page provides complete registration details including trade name (ÖSTERREICHISCHE ROTEN KREUZ), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf Dezernat 24), 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.