Fibreplast® with Integrated Shim™
FDA UDIEUDAMEDClass II (US FDA UDI)
by Qfix
Identity
- Trade Name
- Fibreplast® with Integrated Shim™ FDA UDI
- Generic Name
- Patient positioning thermoplastic mould material FDA UDI
- Device Name
- Fibreplast Hd+Shldr Portrait S-Frame, 2.4mm Std Perf w/ Integrated Shim FDA UDI
- Model / Reference
- RT-A782KSD EUDAMEDFDA UDIAquaplast RT and Fibreplast EUDAMED
- Description
- Fibreplast Hd+Shldr Portrait S-Frame, 2.4mm Std Perf w/ Integrated Shim FDA UDI
Identifiers
- Catalog Number
- RT-A782KSD FDA UDI
- Primary DI / UDI-DI
- 10841962117897 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 — 2.4 Millimeter FDA UDI
Category: Patient positioning thermoplastic mould material
Fibreplast® with Integrated Shim™ 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 97f27f2d-9e7b-4e95-828a-fd21e695631d 36 fields · synced Aug 1, 2026
- EUDAMED c23d845c-9a22-43d5-96cd-344994cc3631 61 fields · synced Jul 28, 2026