Captor ®
by Shanghai HeartCare Medical Technology Corporation Limited China EUDAMED
Ref HC*TDE-6030Model HC*TDE-4020； HC*TDE-4040 ；HC*TDE-6020 ；HC*TDE-6030
EMDN C010401020501
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697114548TDERF | Date30 Jan 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- M.2023.MDR.1027-1 Withdrawn
Technical documentation EU MDR
- Notified body
- UDEM Adriatic d.o.o. 2696
- Issued
- 14 Nov 2023
- Expires
- 13 Nov 2026
- Reason
- Other
Specification
- Device Name
- Thrombectomy Device
- Model / Reference
- HC*TDE-4020； HC*TDE-4040 ；HC*TDE-6020 ；HC*TDE-6030, HC*TDE-6030
- Primary DI / UDI-DI
- 06971145482058
- Basic UDI-DI
- 697114548TDERF
- EMDN Code
- C010401020501 Manual cardiac thrombectomy and thromboaspiration systems
- Device Class
- Class III
- Market of Registration
- Croatia
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 (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 (1)
- EUDAMED 2db31e36-212e-4780-bea2-85d2b357cd5c