CT-7 Tactical Traction Splint W/2 Leg Slings
EUDAMEDFDA UDIClass I (EU MDR)
by FareTec Inc
Identity
- Trade Name
- CT-7 Tactical Traction Splint W/2 Leg Slings EUDAMEDCT-7 Traction splint FDA UDI
- Generic Name
- First aid limb splint, non-mouldable, reusable FDA UDI
- Device Name
- Traction Splints EUDAMEDCT-7 Tactical leg traction splint with set of two leg slings FDA UDI
- Model / Reference
- 1126627-2 EUDAMEDTactical/2 slings FDA UDI
- Description
- CT-7 Tactical leg traction splint with set of two leg slings FDA UDI
Identifiers
- Catalog Number
- 1126627-2 FDA UDI
- Primary DI / UDI-DI
- B541112662720 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Cotton wool roll, sterile
CT-7 Tactical Traction Splint W/2 Leg Slings by Faretec, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 5b2b1aeb-90c8-4cb4-a762-a986d92a74c1 61 fields · synced Jul 14, 2026
- FDA UDI 3e3cb063-49e3-4627-a182-62cb7925bec6 35 fields · synced May 29, 2026