Identity
- Trade Name
- RadQual EUDAMED
- Device Name
- Point, Siemans Symbia, AQC option, Co-57, 50uCi (1.85MBq) EUDAMED
- Model / Reference
- BMSY-57-050 EUDAMEDBMSY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850020470532 EUDAMED
- Basic UDI-DI
- 0085002047POINTQ3 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
RadQual by Radnostix — 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 | 0085002047POINTQ3 | Class I | Active |
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Manufacturer
- Manufacturer
- Radnostix, Inc.
- EUDAMED SRN
- US-MF-000009369
- Authorised Representative
- CERT3GLOBAL, UNIPESSOAL, LDA. PT-AR-000037982
Sources (1)
- EUDAMED 859e263a-e7c9-4ae0-8484-9e4cf97e9d30 61 fields · synced Jul 9, 2026