Identity
- Trade Name
- Batrik SaveFace Disposable Shoe Covers\Dispenser box FDA UDI
- Generic Name
- Shoe cover, conductive, non-sterile FDA UDI
- Device Name
- Shoe Covers EUDAMEDSaveFace Shoe Covers, anti skid, universal size, Blue FDA UDI
- Model / Reference
- SF-SC02UV EUDAMEDFDA UDI
- Description
- SaveFace Shoe Covers, anti skid, universal size, Blue FDA UDI
Identifiers
- Catalog Number
- SF-SC02UV FDA UDI
- Primary DI / UDI-DI
- 00690521017030 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210SCOVERS1006E EUDAMED
- FDA Product Code
- FXP FDA UDI
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
- GMDN Term
- Shoe cover, conductive, non-sterile FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Shoe Covers 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 | 6905210SCOVERS1006E | 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 93930c7e-f2ac-4046-bf74-710212237d8f 61 fields · synced May 29, 2026
- FDA UDI 42832e1a-8153-401c-9be8-0989ea963126 36 fields · synced May 29, 2026