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Rt-E778kpr2ne
EUDAMEDClass I (EU MDR)
Ref RT-E778KPR2NEModel Aquaplast RT and Fibreplast
by Qfix
Identity
- Model / Reference
- Aquaplast RT and Fibreplast EUDAMEDRT-E778KPR2NE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841962120517 EUDAMED
- Basic UDI-DI
- 8419621RTTHERMOPF EUDAMED
- Unit of Use DI
- 10841962120514 EUDAMED
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Rt-E778kpr2ne by Qfix — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8419621RTTHERMOPF | Class I | Active |
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Manufacturer
- Manufacturer
- Qfix
- EUDAMED SRN
- US-MF-000002762
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED a311646e-9d01-4f01-b069-d6cac90448c7 61 fields · synced Jun 18, 2026