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Anjon Bremer Halo System

by G-5 Florida LLC dba Anjon Medical Technologies, dba Anjon Holdings, dba Anjon, dba Generix Medical. 33 variants

Ref 100057

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00810592030671BG Basic UDI-DI 00810592030671UDI-DIDate6 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810592030671 UDI-DI Date1 Apr 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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

Generic Name
Orthopaedic bone pin, non-bioabsorbable
Device Name
Torque Driver Set (Tips)
Model / Ref / Catalog
100057, Titanium Torque Driver set
Primary DI / UDI-DI
00810592030671
Basic UDI-DI
00810592030671BG
FDA Product Code
JEC
EMDN Code
P09120499 External bone fixation systems - other
GMDN Term
Orthopaedic bone pin, non-bioabsorbable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3040
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
100057
GUDID
Titanium Torque Driver set
Device ClassEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
US-MF-000028150
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from G-5 Florida LLC dba Anjon Medical Technologies, dba Anjon Holdings, dba Anjon, dba Generix Medical.

See all devices from G-5 Florida LLC dba Anjon Medical Technologies, dba Anjon Holdings, dba Anjon, dba Generix Medical. →

Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: 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
  • Expiration Date: No