Sealsac
by Shanghai HeartCare Medical Technology Corporation Limited China EUDAMED
Ref ECS-3.5-6-3D-STDModel ECS-4-6-HX-SS
EMDN C010402020301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697114548ECSPV | Date31 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
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-4-6-HX-SS, ECS-3.5-6-3D-STD
- Primary DI / UDI-DI
- 06971145487497
- Basic UDI-DI
- 697114548ECSPV
- 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 Co., Ltd.
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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 06971145487497|697114548ECSPV