Pure Global
00690521002838

NON-STERILE SKINS™ Skin Markers

Batrik Medical Manufacturing Inc.·Class I·EU EUDAMEDNo
Device classification
Risk class
Class I
CND nomenclatures code
V9004
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00690521002838
Basic UDI
6905210SKINSNS1000SN
Version date
November 20, 2024
Manufacturer last update
April 25, 2024
Active status
No
Manufacturer
Manufacturer name
Batrik Medical Manufacturing Inc.
Country
Canada
Country type
NON_EU
Address
2165 46th Ave. Lachine
Email
info@surgmed.com
Authorized representative
Name
Advena Limited
SRN
MT-AR-000000234
Country
Malta
Address
Tower Street Swatar
Email
prrc@advena.mt
Regulatory information
Competent authority
Malta Medicines Authority
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Austria
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

SKIN MARKING DERMOGRAPHIC PENCILS AND PENS

About this record

Access comprehensive regulatory information for NON-STERILE SKINS™ Skin Markers 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 00690521002838 and manufactured by Batrik Medical Manufacturing Inc. in Canada.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Malta Medicines Authority), 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.