Identity
- Trade Name
- AlignRT 8.1.x EUDAMED
- Device Name
- AlignRT Plus EUDAMED
- Model / Reference
- AlignRT 8.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056190501211 EUDAMED
- Basic UDI-DI
- 5056190500573VE EUDAMED
- Direct Marketing DI
- 05056190501211 EUDAMED
- EMDN Code
- Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
AlignRT 8.1.x by Vision RT Ltd. — Class IIb — 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 | 5056190500573VE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Vision RT Ltd.
- EUDAMED SRN
- GB-MF-000010499
- Authorised Representative
- Oticon A/S DK-AR-000006135
Sources (1)
- EUDAMED 55fd54dd-4c0b-40a0-86ea-5edbbddda2c6 61 fields · synced Jul 14, 2026