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Surgical Skin Marker
EUDAMEDClass I (EU MDR)
Ref SU010111Model 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 EUDAMEDSU010111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09341601006703 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSSM0018Z 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 (1)
- EUDAMED d09a900e-49c0-4e57-b6b4-08869b999b0a 61 fields · synced Jun 19, 2026