Identity
- Trade Name
- Brook M Agile EUDAMED
- Device Name
- Brook EUDAMED
- Model / Reference
- Brook L EUDAMEDFG0020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290016441154 EUDAMED
- Basic UDI-DI
- 7290016441003W7 EUDAMED
- EMDN Code
- C010402020380 EMBOLISATION DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Brook M Agile by Perflow Medical Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7290016441003W7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Perflow Medical Ltd.
- EUDAMED SRN
- IL-MF-000009315
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (1)
- EUDAMED 9cb8bd1e-499b-4fc3-b505-644ad7e24ac4 61 fields · synced Aug 1, 2026