Article 22 Comb. Luminos dRF Max
Ref 11573994Model MDR_SPPP_16_IIb_ERLNH127_Combination_Fluoro
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0405686902007UX 04056869295596 | Date9 Oct 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- MDR_SPPP_16_IIb_ERLNH127_Combination_Fluoro
- Model / Reference
- MDR_SPPP_16_IIb_ERLNH127_Combination_Fluoro, 11573994
- Primary DI / UDI-DI
- 04056869295596
- Basic UDI-DI
- 0405686902007UX
- EMDN Code
- Z11039009 Fluoroscopy devices
- Device Class
- Class IIb
- Medical Purpose
- Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
Manufacturer details
- EUDAMED SRN
- DE-PR-000020469
Other devices from Siemens Healthcare GmbH
Properties
Other properties (1)
- Sterile: No