Ultrasonograf ALBIT
by Echo-Son SA Poland EUDAMED
Ref 5904292005000Model ALBIT EMDN Z11040101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05904292005000 | Date8 Nov 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
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
- Ultrasonograf ALBITAlbit
- Device Name
- Utrasound scanner
- Model / Reference
- ALBIT, 5904292005000
- Primary DI / UDI-DI
- 05904292005000
- Basic UDI-DI
- B-05904292005000, 5904292005000YD
- Direct Marketing DI
- 05904292005000
- EMDN Code
- Z11040101, Z11040104
- Device Class
- Class IIa
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000004830
From the manufacturer
Manufacturer's product page: Albit Ultrasonograf
Other devices from Echo-Son SA
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED 0ccf3892-e89c-41b7-9b5e-0c4aa85e4538
- EUDAMED 05904292005000|5904292005000YD