Brook L
by Perflow Medical Ltd. Israel EUDAMED
Ref FG0017Model Brook L
EMDN C010402020380
Regulatory status
Withdrawn since 15 Dec 2025. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1000169818 | Date15 May 2024 | StatusWithdrawn |
Coverage
- Withdrawn
- Not covered
European Union — CE/MDR Withdrawn
Certificates
- 1000169818 Suspended
Quality management system EU MDR
- Notified body
- Notified body 0297
- Issued
- 15 May 2024
- Expires
- 6 Oct 2027
- Reason
- Failure contractual obligations
Specification
- Device Name
- Brook
- Model / Reference
- Brook L, FG0017
- Primary DI / UDI-DI
- 07290016441123
- Basic UDI-DI
- 7290016441003W7
- EMDN Code
- C010402020380 Embolisation devices - accessories
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- IL-MF-000009315
- Authorised representative
- MedNet EC-REP III GmbH DE-AR-000011191
Other devices from Perflow Medical Ltd.
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 858f4ca6-9d6e-4a8e-a7a6-f286dccd1502