Identity
- Trade Name
- Dermark EUDAMED
- Device Name
- Surgical Skin Marker EUDAMED
- Model / Reference
- GS-6028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265602807 EUDAMED
- Basic UDI-DI
- 8907265G017ZU EUDAMED
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Iceland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dermark by Romsons Group Private Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8907265G017ZU | Class I | Active |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 027ecf1b-ca57-4c6b-a15e-a2a92dc5d54c 61 fields · synced Jul 9, 2026