Fibreplast® Assure™ Open View
FDA UDIEUDAMEDClass II (US FDA UDI)
by Qfix
Identity
- Trade Name
- Fibreplast® Assure™ Open View FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- Assure Open View Fibreplast 48 cm Hd+Shldr BoS Flap, 3.2 mm FDA UDI
- Model / Reference
- RT-1878KBOS-E2LF EUDAMEDFDA UDIAquaplast RT and Fibreplast EUDAMED
- Description
- Assure Open View Fibreplast 48 cm Hd+Shldr BoS Flap, 3.2 mm FDA UDI
Identifiers
- Catalog Number
- RT-1878KBOS-E2LF FDA UDI
- Primary DI / UDI-DI
- 10841962114841 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621RTTHERMOPF EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Patient positioning thermoplastic mould material FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Depth — 3.2 Millimeter FDA UDI
Category: Patient positioning thermoplastic mould material
Fibreplast® Assure™ Open View by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI 154c2b87-8165-46d9-b10a-400226039041 36 fields · synced Aug 2, 2026
- EUDAMED 5a9d309d-e170-451e-87cd-47ae9e237c32 61 fields · synced Aug 2, 2026