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Surgify Halo
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 40.125.NVG.H1Model Surgify Halo510(k) K232684
Identity
- Trade Name
- Surgify Halo EUDAMEDSurgify Halo | 4.0 mm | Long FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- Surgify Halo EUDAMED
- Model / Reference
- Surgify Halo EUDAMED40.125.NVG.H1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06429811532243 EUDAMED06429811532083 FDA UDI
- Basic UDI-DI
- 64298301169SurgifyHaloSE EUDAMED
- FDA Product Code
- HBE FDA UDI
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic bur, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4310 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Surgify Halo by Surgify Medical Oy — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232684 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 64298301169SurgifyHaloSE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Surgify Medical Oy
- EUDAMED SRN
- FI-MF-000017137
Sources (3)
- EUDAMED a440b163-61ee-467d-b6f9-6e92a24eade0 85 fields · synced Jun 18, 2026
- FDA UDI 30758f4e-cd3c-4ee0-97e4-517fd3cfeafc 32 fields · synced May 30, 2026
- FDA 510(k) K232684 1 fields · synced May 18, 2026