Identity
- Trade Name
- Surgify Halo EUDAMED
- Device Name
- Surgify Halo EUDAMED
- Model / Reference
- Surgify Halo EUDAMED30.125.NVG.H2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06429811532182 EUDAMED
- Basic UDI-DI
- 64298301169SurgifyHaloSE EUDAMED
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Category: General internal orthopaedic fixation system implantation kit
Surgify Halo by Surgify Medical Oy — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 64298301169SurgifyHaloSE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Surgify Medical Oy
- EUDAMED SRN
- FI-MF-000017137
Sources (1)
- EUDAMED 4f01cf51-ee61-4bfc-a960-87809cdba29d 61 fields · synced May 23, 2026