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Surgify Halo

by Surgify Medical Oy 6 variants

Ref 54.125.NVG.H1Model Surgify Halo

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06429811532359 UDI-DI Date2 Apr 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number64298301169SurgifyHaloSE Basic UDI-DI Date17 Jan 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Surgify Halo EUDAMED
Surgify Halo | 5.4 mm | Long GUDID
Generic Name
Orthopaedic bur, single-use
Model / Reference
Surgify Halo, 54.125.NVG.H1
Primary DI / UDI-DI
06429811532359 EUDAMED
06429811532441 EUDAMED
06429811532106 GUDID
Basic UDI-DI
64298301169SurgifyHaloSE
FDA Product Code
HBE
EMDN Code
V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
GMDN Term
Orthopaedic bur, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4310
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06429811532359
06429811532441
GUDID
06429811532106
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000017137

Related devices

Category: General internal orthopaedic fixation system implantation kit

Other devices from Surgify Medical Oy

See all devices from Surgify Medical Oy →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No