Identity
- Trade Name
- Batrik ShoozCovers™ FDA UDI
- Generic Name
- Shoe cover FDA UDI
- Device Name
- Shoe Covers EUDAMEDShoozCovers™ Disposable Shoe Covers, X-Large, Shoe size 11 – 15, ~ 47 cm x 19 cm / 18.5” x 7.5” FDA UDI
- Model / Reference
- SC-1226-PDB EUDAMEDFDA UDI
- Description
- ShoozCovers™ Disposable Shoe Covers, X-Large, Shoe size 11 – 15, ~ 47 cm x 19 cm / 18.5” x 7.5” FDA UDI
Identifiers
- Catalog Number
- SC-1226-PDB FDA UDI
- Primary DI / UDI-DI
- 00690521019218 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 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
Yes
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 62c4c534-bfcd-454c-a44e-59f714abf097 61 fields · synced May 31, 2026
- FDA UDI 06977b26-90ac-4084-945c-270b21a9aedb 36 fields · synced May 27, 2026