Marie Pacs
by OR-CZ spol. s r.o. Czechia EUDAMED
Ref MPACS-AAAA-MMRRModel MARIE PACS EMDN Z110603
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2023-MDR/QS-007/A | Date26 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2023-MDR/QS-007/A Amended
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 26 May 2026
- Expires
- 23 May 2028
- Reason
- Other
Specification
- Model / Reference
- MARIE PACS, MPACS-AAAA-MMRR
- Primary DI / UDI-DI
- 08594212710014
- Basic UDI-DI
- 859421271MARIEPACSNL
- Direct Marketing DI
- 08594212710014
- EMDN Code
- Z110603 Picture archiving and communication systems
- Device Class
- Class IIb
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000028433
Other devices from OR-CZ spol. s r.o.
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 9b540e19-7528-4c51-9503-d1d9321e09de