Surgify Halo
by Surgify Medical Oy 7 variants
Ref 100-54-TMModel Surgify Halo
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number64298301169SurgifyHaloSE 06429830116912 | Date17 Jan 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Surgify Halo, 100-54-TM
- Primary DI / UDI-DI
- 06429830116912
- Basic UDI-DI
- 64298301169SurgifyHaloSE
- EMDN Code
- V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
- Device Class
- Class IIa
- EU market of registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000017137
Other devices from Surgify Medical Oy
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