Sp-Gripflow
by Fuji Systems Corporation, Shirakawa Plant 6 variants
Ref 1182212Model TYPE I, 12FR
Active
CE MDR
Valid until
13 May 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number45440501910LM 04544050125925 | Date30 Jul 2026 | StatusActive |
Certificates
- MDR 810807 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 14 May 2026
- Expires
- 13 May 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Selective Cerebral Perfusion Catheter
- Model / Reference
- TYPE I, 12FR, 1182212
- Primary DI / UDI-DI
- 04544050125925
- Basic UDI-DI
- 45440501910LM
- EMDN Code
- C03010405 Selective carotid artery and coronary sinus perfusion cannulas
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- JP-MF-000006591
- Authorised representative
- MedDevConsult GmbH DE-AR-000005877
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Properties
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