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Radiosurgical Units
EUDAMEDClass IIb (EU MDR)
Ref RD-General-Dm-0002Model Meg1-R
Identity
- Device Name
- Radiosurgical Units EUDAMED
- Model / Reference
- Meg1-R EUDAMEDRD-General-Dm-0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06260898462609 EUDAMED
- Basic UDI-DI
- B-06260898462609 EUDAMED
- EMDN Code
- Z12010905 RADIOSURGICAL UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Radiosurgical Units by Kavandish System Engineering Co. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06260898462609 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Kavandish System Engineering Co.
- EUDAMED SRN
- IR-MF-000014010
- Authorised Representative
- Trionara Technologies AB SE-AR-000005045
Sources (1)
- EUDAMED 49784ba9-401d-4e80-be80-7b0951f31a71 61 fields · synced Jul 20, 2026