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Skin Marker, Standard Tip Plus Label
EUDAMEDClass I (EU MDR)
Ref PS3150LModel TF-1008
Identity
- Trade Name
- Skin Marker, Standard Tip Plus Label EUDAMED
- Device Name
- Skin Market, Standard Tip, with Label EUDAMED
- Model / Reference
- TF-1008 EUDAMEDPS3150L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223009177 EUDAMED
- Basic UDI-DI
- B-05051223009177 EUDAMED
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Skin Marker, Standard Tip Plus Label by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05051223009177 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 57c448a5-98f3-4e05-a488-45b2d70e850f 61 fields · synced Oct 6, 2026