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Pelvic Binder EMS Blue w Traction Attachment
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8003005
by FareTec Inc
Identity
- Trade Name
- Pelvic Binder EMS Blue w Traction Attachment EUDAMEDPelvic Binder FDA UDI
- Generic Name
- Pelvic fracture binder, single-use FDA UDI
- Device Name
- Pelvic binder EUDAMEDPelvic Binder, EMS, Blue with traction attachment FDA UDI
- Model / Reference
- 8003005 EUDAMEDPelvic Binder, EMS Blue w/traction attachment FDA UDI
- Description
- Pelvic Binder, EMS, Blue with traction attachment FDA UDI
Identifiers
- Catalog Number
- 8003005 FDA UDI
- Primary DI / UDI-DI
- B54180030050 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 Blue 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 f6e91f68-84b1-4f3c-9ddd-4486e853d738 61 fields · synced Jun 19, 2026
- FDA UDI d9db2d13-c84f-4cda-b254-e0b58826e91b 35 fields · synced May 29, 2026