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Frameless SRS MASK SET CRANIAL (1 PC.)
EUDAMEDClass I (EU MDR)
Ref 43610-01
by Brainlab SE
Identity
- Trade Name
- Frameless SRS MASK SET CRANIAL (1 PC.) EUDAMED
- Device Name
- Frameless SRS EUDAMED
- Model / Reference
- 43610-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056481147013 EUDAMED
- Basic UDI-DI
- 4056481FramelessCT EUDAMED
- EMDN Code
- Z11019080 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Multi-modality therapeutic radiation phantom, test object
Frameless SRS MASK SET CRANIAL (1 PC.) by Brainlab SE — 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 | 4056481FramelessCT | Class I | Active |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (1)
- EUDAMED b067834f-e165-4665-b601-a34e3de0c1b7 61 fields · synced Jun 18, 2026