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XMark - EUDAMED Registration 05056256109818

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 05056256109818 and manufactured by CellPath Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (XMARK - TISSUE MARKING DYE - TEAL - 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.

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EUDAMED Official Data
Class A
05056256109818
No
XMark
Trade Name: XMARK - TISSUE MARKING DYE - TEAL - 60ML BOTTLE
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Device Description (EMDN)

STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W01030708
Trade Name
XMARK - TISSUE MARKING DYE - TEAL - 60ML BOTTLE
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05056256109818
Basic UDI
05056256RCA00144
Version Date
March 06, 2025
Manufacturer Last Update
September 02, 2024
Active Status
No
Manufacturer
Manufacturer Name
CellPath Ltd
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Unit 80 Mochdre Indstl Estate NEWTOWN, Powys
Email
regulatory@cellpath.com
Authorized Representative
SRN
NL-AR-000000116
Country
Netherlands
Address
60 Westervoortsedijk Arnhem
Email
lst.aus.euauthrep@ul.com
Telephone
+31 70 345 8570
Regulatory Information
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
Device Characteristics
Human Tissues
No
Animal Tissues
No