Identity
- Trade Name
- Batrik Skins FDA UDI
- Generic Name
- Skin marking pen, single-use FDA UDI
- Device Name
- Sterile SKINS™ Skin Markers EUDAMEDSurgical Skin Markers, Multi-Tip fine Marker with Ruler and Label Set, Sterile FDA UDI
- Model / Reference
- S-3000 EUDAMEDFDA UDI
- Description
- Surgical Skin Markers, Multi-Tip fine Marker with Ruler and Label Set, Sterile FDA UDI
Identifiers
- Catalog Number
- S-3000 FDA UDI
- Primary DI / UDI-DI
- 00690521002791 EUDAMED00690521014916 FDA 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
No
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 896b66b7-0254-4978-99be-42cd66c29b3b 61 fields · synced Jul 19, 2026
- FDA UDI 8b4c33bd-e82b-4e15-9b24-6164e3acf87d 36 fields · synced May 30, 2026