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Xmark - Tissue Marking Dye - Magenta - 60ml Bottle
EUDAMEDClass A (EU MDR)
Ref RCA-0127-00BRef RCA-0127-00A
by CellPath Ltd
Identity
- Trade Name
- XMARK - TISSUE MARKING DYE - MAGENTA - 60ML BOTTLE EUDAMED
- Device Name
- XMark EUDAMED
- Model / Reference
- RCA-0127-00B EUDAMEDRCA-0127-00A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056256109832 EUDAMED05056256114201 EUDAMED
- Basic UDI-DI
- 05056256RCA00144 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Xmark - Tissue Marking Dye - Magenta - 60ml Bottle by CellPath Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 05056256RCA00144 | Class A | Active |
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Manufacturer
- Manufacturer
- CellPath Ltd
- EUDAMED SRN
- GB-MF-000022744
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fc332224-0c5f-40af-b77f-677ad76d1699 61 fields · synced Jul 16, 2026
- EUDAMED 321fe978-e13d-4b86-b959-c2db4c35273b 61 fields · synced May 18, 2026