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Redi Universal Splint, Extra Small, Black, Folded
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1211350
by FareTec Inc
Identity
- Trade Name
- Redi Universal Splint, Extra Small, Black, Folded EUDAMEDRedi Splint FDA UDI
- Generic Name
- First aid limb splint, mouldable, single-use FDA UDI
- Device Name
- Redi Splint EUDAMEDRedi Universal Splint, black, folded, 3.5x18 FDA UDI
- Model / Reference
- 1211350 EUDAMEDRedi Universal Splint FDA UDI
- Description
- Redi Universal Splint, black, folded, 3.5x18 FDA UDI
Identifiers
- Catalog Number
- 1211350 FDA UDI
- Primary DI / UDI-DI
- B54112113500 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B5411211VT EUDAMED
- FDA Product Code
- NOC FDA UDI
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
- GMDN Term
- First aid limb splint, mouldable, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3910 FDA UDI
- Market of Registration
- Slovakia 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
Redi Universal Splint, Extra Small, Black, Folded by Faretec, 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 | ++B5411211VT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FareTec Inc
- EUDAMED SRN
- US-MF-000014693
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 43a2d160-34a2-4a13-a1a8-b2d89c0ab7e6 61 fields · synced Jun 18, 2026
- FDA UDI c1facf41-693f-4ab4-81d8-5875597b1da1 35 fields · synced May 30, 2026