CT-Lokalisations Set für Titan- und Aluminiumring
Ref 809050Model 809000
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number42503076FZS010AL 04250307606658 | Date23 Oct 2025 | StatusActive |
| United States | GUDID listing GUDID | Number04250307606658 | Date27 Sep 2022 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Neurological stereotactic surgery system
- Device Name
- Angio-/Röntgen-Lokalisations-Set, bestehend aus:
- Model / Reference
- 809000, 809050
- Primary DI / UDI-DI
- 04250307606658
- Basic UDI-DI
- 42503076FZS010AL
- Direct Marketing DI
- 04250307606658
- FDA Product Code
- IYE
- EMDN Code
- Z12100680 Stereotactic neurosurgery instruments - hardware accessories
- GMDN Term
- Neurological stereotactic surgery system
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 892.5050
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- DE-MF-000005589
Other devices from inomed Medizintechnik GmbH
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No