synedra AIM 26 Helena
by synedra information technologies GmbH Austria EUDAMED
Ref 26 Helena EMDN Z110603
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number912010070aimHG | Date9 May 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 1000326253 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 22 Sep 2026
- Expires
- 1 Dec 2026
- Reason
- Change approved
- 170780826 Withdrawn
Technical documentation EU MDR
- Notified body
- Notified body 0297
- Issued
- 25 Jul 2022
- Expires
- 15 Dec 2026
- Reason
- Other
Specification
- Device Name
- synedra AIM
- Model / Reference
- 26 Helena
- Primary DI / UDI-DI
- 09120100700264
- Basic UDI-DI
- 912010070aimHG
- Direct Marketing DI
- 09120100700264
- EMDN Code
- Z110603 Picture archiving and communication systems
- Device Class
- Class IIb
- Special Device Type
- Software
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- AT-MF-000000903
Other devices from synedra information technologies GmbH
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 (1)
- EUDAMED 09120100700264|912010070AIMHG