Surgify Halo
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Surgify Halo EUDAMEDSurgify Halo | 5.4 mm | Long FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- Surgify Halo EUDAMED
- Model / Reference
- Surgify Halo EUDAMED30.070.NVG.H2 EUDAMED30.000.SEE.H2 EUDAMED54.125.NVG.H1 EUDAMEDFDA UDI100-54-TL EUDAMED100-54-TM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06429811532175 EUDAMED06429811532199 EUDAMED06429811532359 EUDAMED06429830116905 EUDAMED06429830116912 EUDAMED06429811532106 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 (6)
- EUDAMED 21f4a7d0-3314-4237-87ad-e7ca3d02e92b 61 fields · synced Sep 17, 2026
- EUDAMED d56dd8aa-778a-4ebf-8f33-7e6d6c89fc39 61 fields · synced May 18, 2026
- EUDAMED 31584ca1-e014-44d2-973a-a4b5edccd02f 61 fields · synced May 18, 2026
- EUDAMED b1dca693-8dcb-4587-a9ea-18be3effa538 61 fields · synced May 18, 2026
- EUDAMED 8e552c6e-76fd-4f27-9f7c-e22828978754 61 fields · synced May 18, 2026
- FDA UDI fb68f8d0-a54a-4548-8d0d-f65f24b04135 32 fields · synced May 30, 2026