Identity
- Device Name
- NON-STERILE SKINS™ Skin Markers EUDAMED
- Model / Reference
- S-94000 EUDAMEDS-95000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00690521002869 EUDAMED00690521002883 EUDAMED
- Basic UDI-DI
- 6905210SKINSNS1000SN EUDAMED
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
NON-STERILE SKINS™ Skin Markers by Batrik Medical Manufacturing Inc. — 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 | 6905210SKINSNS1000SN | Class I | Active |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED b7fc4b57-78cb-4a83-b742-22a178704773 61 fields · synced Jul 30, 2026
- EUDAMED f81c4411-9a18-4320-b52b-4503529573d6 61 fields · synced May 17, 2026