Argi̇ Grup
by Argi̇ Grup Sağlik Hi̇zmetleri̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ Türkiye EUDAMED
Ref ARG12000PLModel EVD
EMDN A060201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number86987537ARG12000PLNR | Date8 Jul 2025 | StatusActive |
| European Union | CE/MDR | Number86987537ARG12000PLNR | Date8 Jul 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR, CE/MDD Active
Certificates
- MDR.2292-2025/0021 Issued
Technical documentation EU MDR
- Notified body
- Notified body 2292
- Issued
- 30 Jun 2025
- Expires
- 29 Jun 2030
- Valid from
- 9 Jul 2025
Specification
- Device Name
- CSF External Ventricular Dranaige and ICP Monitoring SystemCSF External Ventricular Dranaige and ICP Monitorization System
- Model / Reference
- ARG12000PL, EVD
- Primary DI / UDI-DI
- 08698753710264
- Basic UDI-DI
- 86987537ARG12000PLNR, B-08698753710264
- EMDN Code
- A060201 External drainage catheters and kits (abscesses, gallstones, cysts)
- Device Class
- Class III
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000039631
Other devices from Argi̇ Grup Sağlik Hi̇zmetleri̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇
See all devices from Argi̇ Grup Sağlik Hi̇zmetleri̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇ →
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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 7b273f5a-da48-41c9-a4e5-ba739365d75c
- EUDAMED 08698753710264|B-08698753710264