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Ezy-AiD Surgical Skin Marker
EUDAMEDClass I (EU MDR)
Ref TF01Ref R03Ref TF02Ref TS01
Identity
- Trade Name
- Ezy-AiD Surgical Skin Marker EUDAMED
- Device Name
- Surgical Skin Marker EUDAMED
- Model / Reference
- TF01 EUDAMEDR03 EUDAMEDTF02 EUDAMEDTS01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060645212942 EUDAMED05060645212966 EUDAMED05060645212959 EUDAMED05060645212973 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
Ezy-AiD 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 (4)
- EUDAMED de9bf0a7-c97e-4f61-871e-f6e1e2ffb963 61 fields · synced Jul 23, 2026
- EUDAMED 6fa71d6f-6ad6-4ad3-92ca-98f50a0d7a5c 61 fields · synced May 18, 2026
- EUDAMED 9a975683-440f-4e80-b577-e1a68acd9300 61 fields · synced May 19, 2026
- EUDAMED 6c322e48-0c01-4846-9a5c-3d95d8799f1c 61 fields · synced May 19, 2026