Eliminate
by Terumo Clinical Supply Co., Ltd. 3 variants
Ref EG1401
Active
CE MDR
Valid until
7 Dec 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4987350CSELT5Y 04543334181404 | Date14 Oct 2026 | StatusActive |
Certificates
- 4202851TD01 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 4 Jun 2025
- Expires
- 31 Jan 2028
- Reason
- Add device or group
- 4202851CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 31 Jan 2023
- Expires
- 7 Dec 2027
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- EG1401
- Primary DI / UDI-DI
- 04543334181404
- Basic UDI-DI
- 4987350CSELT5Y
- EMDN Code
- C010401020501 Manual cardiac thrombectomy and thromboaspiration systems
- Device Class
- Class III
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- JP-MF-000029140
- Authorised representative
- TERUMO EUROPE N.V. BE-AR-000001433
Other devices from Terumo Clinical Supply Co., Ltd.
Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No