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purple surgical Skin Marker
EUDAMEDClass I (EU MDR)
Ref PS3158ANSRef PS3150ARef PS3150ANSRef PS3151ARef PS3158A
Identity
- Trade Name
- purple surgical Skin Marker EUDAMED
- Device Name
- Surgical Skin Marker EUDAMED
- Model / Reference
- PS3158ANS EUDAMEDPS3150A EUDAMEDPS3150ANS EUDAMEDPS3151A EUDAMEDPS3158A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 35051223038277 EUDAMED05051223037392 EUDAMED35051223038253 EUDAMED55051223038271 EUDAMED05051223037408 EUDAMED05051223037415 EUDAMED55051223038257 EUDAMED
- Basic UDI-DI
- 697180265SSMU2 EUDAMED697180265SSSMRJ EUDAMED
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
purple 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 | 697180265SSMU2 | 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 (7)
- EUDAMED 8ec9af2b-0528-427a-946a-a4af377f638b 61 fields · synced Sep 18, 2026
- EUDAMED 7dffb170-0792-440c-914b-6cbca138ba07 61 fields · synced May 17, 2026
- EUDAMED dbc033a8-d859-461e-a59d-cd7b1a642203 61 fields · synced May 17, 2026
- EUDAMED 4ca696b3-9cd8-414d-b34d-15202ab183c6 61 fields · synced May 17, 2026
- EUDAMED eb7400b5-777c-40ec-9632-b961d70b59f6 61 fields · synced May 17, 2026
- EUDAMED a31df603-db6c-40c0-986a-47f834aa6253 61 fields · synced May 19, 2026
- EUDAMED c8863116-3507-40af-a201-9f4dc8699a98 61 fields · synced May 19, 2026