Wallaby Avenir™ Coil System
by Wallaby Medical 110 variants
Ref 10HFL08030Model 10 System Helical Filling Coils 8mm x 30cm
Active
CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-06970908210587 06970908210587 | Date12 Jan 2023 | StatusActive |
| United States | GUDID listing GUDID | Number06970908210587 | Date30 Apr 2021 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Avenir
- Generic Name
- Neurovascular embolization coil
- Device Name
- Wallaby Avenir™ Coil System
- Model / Reference
- 10 System Helical Filling Coils 8mm x 30cm, 10HFL08030
- Primary DI / UDI-DI
- 06970908210587
- Basic UDI-DI
- B-06970908210587
- FDA Product Code
- KRD, HCG
- EMDN Code
- C010402020301 Embolisation coils
- GMDN Term
- Neurovascular embolization coil
- Device Class
- Class III EUDAMEDClass II GUDID
- Regulation Number
- 870.3300, 882.5950
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Conditional
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class III | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000010241
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Wallaby Medical
Properties
Other properties (16)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No