ELiS - Template, D9
Ref 400402
ELiS - Template, D9 (400402) is a Class I device made by BEZNOSKA, s.r.o., registered in EUDAMED on 26 May 2026 (Basic UDI-DI 859260200001EG) with CE/MDR certificate 2024-MDR/QS-057/C valid until 12 May 2028, active as of 25 Oct 2026.
Active
CE MDR
Valid until
12 May 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2024-MDR/QS-057/C | Date29 Sep 2026 | StatusActive |
Official records
- EUDAMED public site 859260200001EG
Certificates
- 2024-MDR/QS-057/C Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 29 Sep 2026
- Expires
- 12 May 2028
- Reason
- Other
Timeline
- Registered EUDAMED 859260200001EG
- Certificate issued EUDAMED 2024-MDR/QS-057/C
- Certificate expires EUDAMED 2024-MDR/QS-057/C
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Reusable surgical instruments
- Model / reference
- 400402
- Primary DI / UDI-DI
- 08592602145330
- Basic UDI-DI
- 859260200001EG
- EMDN code
- L091199 Orthopaedic prosthetics instruments, reusable - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000000543
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