Identity
- Trade Name
- RadQual EUDAMED
- Device Name
- Line Sources EUDAMED
- Model / Reference
- BM68 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810212890913 EUDAMED
- Basic UDI-DI
- 0081021289LINEMU EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Device sterilization/disinfection container, reusable
RadQual by Radnostix — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0081021289LINEMU | 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 8c5628fa-ef30-4b16-8037-0b50314b38c9 61 fields · synced Jul 23, 2026