Identity
- Trade Name
- Siemens Wedge EUDAMED
- Device Name
- Siemens Wedge Filter DI15 EUDAMED
- Model / Reference
- Siemens Wedge EUDAMED56-300-MI45 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B36556300MI450 EUDAMED
- Basic UDI-DI
- ++B36556300DI15EC EUDAMED
- Direct Marketing DI
- +B36556300MI450 EUDAMED
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Siemens Wedge by Aktina Medical Corp — Class I — 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 | ++B36556300DI15EC | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aktina Medical Corp
- EUDAMED SRN
- US-MF-000005935
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 5c861f8b-dbf3-4e0b-ac2a-2b24ebe22588 61 fields · synced Jun 18, 2026