Identity
- Trade Name
- Batrik Reusable Anti-Fatigue FDA UDI
- Generic Name
- Anti-fatigue floor mat FDA UDI
- Device Name
- Anti-Fatigue Mats EUDAMEDBlue Cloud-Gel Anti-Fatigue Mat, reusable, black, 13" x 17" (33 cm x 43 cm) FDA UDI
- Model / Reference
- 809-1705 EUDAMEDFDA UDI
- Description
- Blue Cloud-Gel Anti-Fatigue Mat, reusable, black, 13" x 17" (33 cm x 43 cm) FDA UDI
Identifiers
- Catalog Number
- 809-1705 FDA UDI
- Primary DI / UDI-DI
- 00690521013599 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210ANTIFATIGMAT100EB EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Anti-fatigue floor mat FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Anti-Fatigue Mats 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 | 6905210ANTIFATIGMAT100EB | 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 dd21ed1f-08c9-41d1-a915-63f0f99e46bf 61 fields · synced Jul 29, 2026
- FDA UDI 08771d0d-785e-4281-bd54-e07e2497977b 36 fields · synced May 30, 2026