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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 100043

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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 Number00810592030442AX Basic UDI-DI 00810592030442UDI-DIDate6 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810592030442 UDI-DI Date20 Apr 2018ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Permanent Torque Driver
Model / Ref / Catalog
100043, Torque Pin Driver
Primary DI / UDI-DI
00810592030442
Basic UDI-DI
00810592030442AX
510(k) Number
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
100043
GUDID
Torque Pin Driver
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

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

Other properties (20)

  • Sterile: No
  • Single Use: 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