Sonda OA 12
by Echo-Son SA Poland EUDAMED
Ref 5904292005147Model OA 12 EMDN Z11040299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-05904292005147 | Date19 Nov 2021 | StatusActive |
| European Union | CE/MDD | NumberB-05904292005147 | Date19 Nov 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD Active
Certificates
- 145257-26-07-09 Issued
Quality management system EU MDR
- Notified body
- CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. 2409
- Issued
- 9 Jul 2026
- Expires
- 8 Jul 2031
Specification
- Trade Name
- Sonda OA 12Oa 12
- Device Name
- Sonda ultradźwiękowaUltrasound probe
- Model / Reference
- OA 12, 5904292005147
- Primary DI / UDI-DI
- 05904292005147
- Basic UDI-DI
- B-05904292005147, 5904292005147ZC
- Direct Marketing DI
- 05904292005147
- EMDN Code
- Z11040299 Ultrasound probes – other
- Device Class
- Class IIa
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000004830
Other devices from Echo-Son SA
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: 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
Sources (2)
- EUDAMED 9b3e9a65-e543-474c-9f4f-66e35cf00e23
- EUDAMED 05904292005147|5904292005147ZC