Sealsac
by Shanghai HeartCare Medical Technology Corporation Limited China EUDAMED
Ref ECS-2-3-HX-ESModel ECS-1-1-HX-ES
EMDN C010402020301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR.2292-2026-0081 | Date9 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 1 country, as listed in EUDAMED:
- Türkiyesince 30 Sep 2026
Certificates
- MDR.2292-2026-0081 Issued
Technical documentation EU MDR
- Notified body
- Notified body 2292
- Issued
- 9 Oct 2026
- Expires
- 29 Sep 2031
Specification
- Device Name
- Embolization Coil System
- Model / Reference
- ECS-1-1-HX-ES, ECS-2-3-HX-ES
- Primary DI / UDI-DI
- 06971145487251
- Basic UDI-DI
- 697114548ECS-2D-ESZ6
- EMDN Code
- C010402020301 Embolisation coils
- Device Class
- Class III
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000001941
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shanghai HeartCare Medical Technology Corporation Limited
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- 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 06971145487251|697114548ECS-2D-ESZ6