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TOP-X 100NR High frequency X-ray generator
EUDAMEDClass IIb (EU MDR)
Ref R-7469
by Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság
Identity
- Trade Name
- TOP-X 100NR High frequency X-ray generator EUDAMED
- Device Name
- TOP-X 100NR High Frequency X-ray Generator EUDAMED
- Model / Reference
- R-7469 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TOP-X100NRHV EUDAMED
- Basic UDI-DI
- B-TOP-X100NRHV EUDAMED
- EMDN Code
- Z11039011 HIGH VOLTAGE X-RAY GENERATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Category: Diagnostic x-ray system generator, stationary
TOP-X 100NR High frequency X-ray generator by Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság — Class IIb — MDD — listed…
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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-TOP-X100NRHV | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- HU-MF-000017747
Sources (1)
- EUDAMED 3ac901f3-1775-436c-a7ed-c962a2d198a8 61 fields · synced Jul 9, 2026