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CT-7 Military Leg Traction Splint
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1126627-M
by FareTec Inc
Identity
- Trade Name
- CT-7 Military Leg Traction Splint EUDAMEDCT-7 Traction Splint FDA UDI
- Generic Name
- First aid limb splint, non-mouldable, reusable FDA UDI
- Device Name
- Traction Splints EUDAMEDCT-7 Military Leg Traction Splint FDA UDI
- Model / Reference
- 1126627-M EUDAMEDMilitary FDA UDI
- Description
- CT-7 Military Leg Traction Splint FDA UDI
Identifiers
- Catalog Number
- 1126627-M FDA UDI
- Primary DI / UDI-DI
- B5411126627M0 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
CT-7 Military Leg Traction Splint 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 6f025039-95c7-4c67-8413-f83650aae7bd 61 fields · synced Jun 18, 2026
- FDA UDI c64ca8cf-2cba-45d3-8635-fe108fec5342 35 fields · synced May 29, 2026