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Surgical Skin Marker
EUDAMEDClass I (EU MDR)
Ref SU010116Model Regular tip with ruler ,Regular tip without ruler ,Fine tip with ruler, Fine tip without ruler, Mini type, Dual-tip typeRef SU010114Ref SU010111Ref SU010115
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 EUDAMEDSU010116 EUDAMEDSU010114 EUDAMEDSU010111 EUDAMEDSU010115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013960548 EUDAMED06972013960562 EUDAMED06972013960005 EUDAMED06972013960555 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSSM0018Z EUDAMED
- Direct Marketing DI
- 06972013960548 EUDAMED06972013960562 EUDAMED06972013960005 EUDAMED06972013960555 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 (8)
- EUDAMED 451bb6a2-129d-46ad-8111-cde4a1235f0b 61 fields · synced Jul 15, 2026
- EUDAMED 5b522277-fc70-4504-a513-802d8497c41d 61 fields · synced May 17, 2026
- EUDAMED 312bbf43-4ae0-4e21-9306-a2fc0c92408b 61 fields · synced May 18, 2026
- EUDAMED 568077f9-e3cb-4f76-9a7f-1a85814f138e 61 fields · synced May 18, 2026
- EUDAMED 811089f1-4d70-4836-b6bf-792cb262cc0b 61 fields · synced Jul 12, 2026
- EUDAMED ec953ac3-2850-4e87-8488-e6c20bfc3933 61 fields · synced Jul 14, 2026
- EUDAMED 9e05504a-d057-419d-addf-a89f918de8cc 61 fields · synced Jul 14, 2026
- EUDAMED 6e9dd03c-5e8c-4ded-a48d-99ee09328c47 61 fields · synced Jul 15, 2026