Septoquat AM MD/RFU
by Живас Оод EUDAMED
Active
Ref zh016/10/en/01_RFU, zh016/3/en/01, zh016/1/en/01_RFU, zh016/5/en/01
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number38002282401654 | Date10 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-MDR/QS-047 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 24 Sep 2025
- Expires
- 10 Nov 2028
Specification
- Device Name
- Septoquat AM MD/RFU
- Model / Reference
- zh016/10/en/01_RFU, zh016/3/en/01, zh016/1/en/01_RFU, zh016/5/en/01
- Primary DI / UDI-DI
- 03800228243480, 03800228240410, 03800228242773, 03800228240724
- Basic UDI-DI
- 38002282401654
- EMDN Code
- D0902 Associated ammonium salts for the disinfection of medical devices
- Device Class
- Class IIb
- Market of Registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- BG-MF-000019745
Other devices from Живас Оод
Properties
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