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Rt-4546-04
EUDAMEDClass I (EU MDR)
Ref RT-4546-04Model Breast and Pelvis
by Qfix
Identity
- Model / Reference
- Breast and Pelvis EUDAMEDRT-4546-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841962120418 EUDAMED
- Basic UDI-DI
- 8419621BREASTPELVISTG EUDAMED
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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-4546-04 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 | 8419621BREASTPELVISTG | 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 93ca4664-bbd0-4a39-b8ce-78c71b506832 61 fields · synced Jun 19, 2026