Identity
- Trade Name
- Tondaus Surgical Skin Marker EUDAMEDSurgical Skin Marker EUDAMED
- Device Name
- Surgical Skin Marker EUDAMED
- Model / Reference
- TR01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971802650431 EUDAMED
- Basic UDI-DI
- 697180265SSSMRJ EUDAMEDB-06971802650431 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
Tondaus Surgical Skin Marker by Dongguan Tondaus Meditech Co., Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697180265SSSMRJ | Class I | Active |
| EUDAMED | European Union | CE/MDD | 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 (2)
- EUDAMED 3e06e0d7-211f-40b6-80f6-17cb9fbf5260 61 fields · synced Jun 20, 2026
- EUDAMED 4a30e4db-9748-4c14-a01f-1a8485eac3ea 61 fields · synced May 17, 2026