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Surgical Skin Marker
EUDAMEDClass I (EU MDR)
Ref SU010112Model Regular tip with ruler ,Regular tip without ruler ,Fine tip with ruler, Fine tip without ruler, Mini type, Dual-tip type
Identity
- Trade Name
- Surgical Skin Marker EUDAMED
- Device Name
- Surgical Skin Marker EUDAMED
- Model / Reference
- Regular tip with ruler ,Regular tip without ruler ,Fine tip with ruler, Fine tip without ruler, Mini type, Dual-tip type EUDAMEDSU010112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013960586 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSSM0018Z EUDAMED
- Direct Marketing DI
- 06972013960586 EUDAMED
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
Classification
- Device Class
- Class I 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
Surgical Skin Marker by Multigate 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 | 697201396MU01SNNNSSM0018Z | Class I | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (2)
- EUDAMED 8183a073-bb14-40e3-9ff9-ae0a5b0bec5e 61 fields · synced Jun 19, 2026
- EUDAMED e6720400-8f7e-4baa-8701-6f6c86e0ad8c 61 fields · synced Jun 19, 2026