Identity
- Trade Name
- Batrik SKINS- Marker - Sterile FDA UDI
- Generic Name
- Skin marking pen, single-use FDA UDI
- Device Name
- Sterile SKINS™ Skin Markers EUDAMEDSKINS-Mark/Ruler/Label/Sterile FDA UDI
- Model / Reference
- S-30005 EUDAMEDFDA UDI
- Description
- SKINS-Mark/Ruler/Label/Sterile FDA UDI
Identifiers
- Catalog Number
- S-30005 FDA UDI
- Primary DI / UDI-DI
- 00690521002784 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210SKINSST100AL EUDAMED
- FDA Product Code
- FZZ FDA UDI
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
- GMDN Term
- Skin marking pen, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4660 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Sterile SKINS™ Skin Markers by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6905210SKINSST100AL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 0be3baf5-993a-4cbb-afa7-be33ad7b5817 61 fields · synced Jul 14, 2026
- FDA UDI 4b36bf4b-3232-41ff-90c3-50b69c343403 36 fields · synced May 30, 2026