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Leksell GammaPlan 11.5
EUDAMEDClass IIb (EU MDR)
Ref 1577756Model Leksell GammaPlan
Identity
- Trade Name
- Leksell GammaPlan 11.5 EUDAMED
- Model / Reference
- Leksell GammaPlan EUDAMED1577756 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340201503898 EUDAMED
- Basic UDI-DI
- 073400483BUDI000000001ZQ EUDAMED
- EMDN Code
- Z11010782 RADIOSURGERY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
Leksell GammaPlan 11.5 by Elekta Solutions Ab — 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 | 073400483BUDI000000001ZQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Elekta Solutions AB
- EUDAMED SRN
- SE-MF-000002125
Sources (1)
- EUDAMED 9ebde251-2d9b-4a3a-8ab5-3678e111d393 61 fields · synced Jun 18, 2026