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QD-4 Leg Traction Splint, Adult, Alum
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1126524
by FareTec Inc
Identity
- Trade Name
- QD-4 Leg Traction Splint, Adult, Alum EUDAMEDQD-4 Traction Splint FDA UDI
- Generic Name
- First aid limb splint, non-mouldable, reusable FDA UDI
- Device Name
- Traction Splints EUDAMEDQD-4 Leg Traction Splint with aluminum ratchet, Adult/Pedi FDA UDI
- Model / Reference
- 1126524 EUDAMEDAdult/Pedi, Aluminum FDA UDI
- Description
- QD-4 Leg Traction Splint with aluminum ratchet, Adult/Pedi FDA UDI
Identifiers
- Catalog Number
- 1126524 FDA UDI
- Primary DI / UDI-DI
- B54111265240 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B5411126W3 EUDAMED
- FDA Product Code
- HSP FDA UDI
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
- GMDN Term
- First aid limb splint, non-mouldable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.5890 FDA UDI
- Market of Registration
- Slovakia 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
QD-4 Leg Traction Splint, Adult, Alum 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 | ++B5411126W3 | 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 8888187c-9b5c-45f5-8212-b60fc1811339 61 fields · synced Jul 14, 2026
- FDA UDI 8c75b4d9-1f6a-41c6-9d94-174e071e23c0 35 fields · synced May 30, 2026