Surgify Halo
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Surgify Halo EUDAMEDSurgify Halo | 4.0 mm | Short FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- Surgify Halo EUDAMED
- Model / Reference
- Surgify Halo EUDAMED40.070.NVG.H1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06429811532236 EUDAMED06429811532069 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
Single Use
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General internal orthopaedic fixation system implantation kit
Surgify Halo by Surgify Medical Oy — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 64298301169SurgifyHaloSE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Surgify Medical Oy
- EUDAMED SRN
- FI-MF-000017137
Sources (2)
- EUDAMED e0aba900-cb5e-4020-8542-43085b2316b3 61 fields · synced May 31, 2026
- FDA UDI 2566c7a5-9221-489b-a480-8a713989a256 32 fields · synced May 30, 2026