Tool, Needle Alignment, ACL Series
by Instrumentation Laboratory Company EUDAMED
Active
Ref 00018103941
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number8426950578239A5 | Date8 Sep 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- 00018103941
- Primary DI / UDI-DI
- 08426950578239
- Basic UDI-DI
- 8426950578239A5
- Direct Marketing DI
- 08426950578239
- EMDN Code
- W0202020180 Coagulometers - hardware accessories
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- US-MF-000035586
- Authorised representative
- Instrumentation Laboratory SpA IT-AR-000008169
Other devices from Instrumentation Laboratory Company
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No