XMark
- Risk class
- Class A
- CND nomenclatures code
- W01030708
- Trade name
- XMARK - TISSUE MARKING DYE - MAGENTA - 60ML BOTTLE
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 05056256109832
- Basic UDI
- 05056256RCA00144
- Version date
- March 06, 2025
- Manufacturer last update
- September 02, 2024
- Active status
- No
- Manufacturer name
- CellPath Ltd
- Country
- United Kingdom (ex Northern Ireland)
- Country type
- NON_EU
- Address
- Unit 80 Mochdre Indstl Estate NEWTOWN, Powys
- regulatory@cellpath.com
- SRN
- NL-AR-000000116
- Country
- Netherlands
- Address
- 60 Westervoortsedijk Arnhem
- lst.aus.euauthrep@ul.com
- Telephone
- +31 70 345 8570
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
- Placed on the market
- Netherlands
- Human tissues
- No
- Animal tissues
- No
STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
Access comprehensive regulatory information for XMark in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 05056256109832 and manufactured by CellPath Ltd in United Kingdom (ex Northern Ireland).
This page provides complete registration details including trade name (XMARK - TISSUE MARKING DYE - MAGENTA - 60ML BOTTLE), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), 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.