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Pelvic Binder EMS Red w Traction Attachment
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8003007
by FareTec Inc
Identity
- Trade Name
- Pelvic Binder EMS Red w Traction Attachment EUDAMEDPelvic Binder FDA UDI
- Generic Name
- Pelvic fracture binder, single-use FDA UDI
- Device Name
- Pelvic binder EUDAMEDPelvic Binder, EMS Red, with traction attachment FDA UDI
- Model / Reference
- 8003007 EUDAMEDPelvic Binder EMS Red w/traction attachment FDA UDI
- Description
- Pelvic Binder, EMS Red, with traction attachment FDA UDI
Identifiers
- Catalog Number
- 8003007 FDA UDI
- Primary DI / UDI-DI
- B54180030070 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B5418003X3 EUDAMED
- FDA Product Code
- IPW FDA UDI
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
- GMDN Term
- Pelvic fracture binder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3490 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
Pelvic Binder EMS Red w Traction Attachment 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 | ++B5418003X3 | 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 9a2c10f3-c7fb-42b3-9eee-dc636508d16b 61 fields · synced Jun 20, 2026
- FDA UDI 7d0ee1dc-be37-496f-92c7-ce4d2843aeb6 35 fields · synced May 30, 2026