Identity
- Trade Name
- Fannin Surgical Skin Marker EUDAMED
- Device Name
- Surgical Skin Marker EUDAMED
- Model / Reference
- SM0472 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971802651476 EUDAMED
- Basic UDI-DI
- 697180265SSSMRJ EUDAMED
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Fannin Surgical Skin Marker by Dongguan Tondaus Meditech Co., Ltd. — 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 | 697180265SSSMRJ | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Tondaus Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000023652
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 7d0d699c-3e31-41a2-bd2d-cb715c2e884f 61 fields · synced Jun 18, 2026