Z-Lock
by Koelis
Ref KRZL.EXModel Z-LOCK
Z-Lock (KRZL.EX) is a Class I device made by Koelis, registered in EUDAMED on 25 Oct 2022 (Basic UDI-DI 3665134Zlock_01NE), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3665134Zlock_01NE 03665134000653 | Date25 Oct 2022 | StatusActive |
Official records
- EUDAMED public site 3665134Zlock_01NE
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- Z-LOCK, KRZL.EX
- Primary DI / UDI-DI
- 03665134000653
- Basic UDI-DI
- 3665134Zlock_01NE
- Direct marketing DI
- 03665134000653
- EMDN code
- Z11049080 Various ultrasound instruments - hardware accessories
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000000830
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