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joimax® Guide Wire, super elastic, unsterile

by Joimax GmbH 2 variants

Ref TGWS30008

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

CE MDR CE MDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-04250337112945 Basic UDI-DI 04250337112945UDI-DIDate21 Feb 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-04250337112945 Basic UDI-DI 04250337112945UDI-DIDate21 Feb 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337112945 UDI-DI Date30 Dec 2022ListedStatusListed 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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
joimax® Guide Wire, super elastic, unsterile EUDAMED
guide wire GUDID
Generic Name
Orthopaedic bone wire
Device Name
Guide Wire with marker, straight, non-sterile
Model / Ref / Catalog
TGWS30008
Primary DI / UDI-DI
04250337112945
Basic UDI-DI
B-04250337112945, 42503371GUWIGUWPV
Direct Marketing DI
04250337112945
FDA Product Code
FZX
EMDN Code
L0922 Orthopaedic surgery guides, reusable
GMDN Term
Orthopaedic bone wire
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
EU market of registration
Austria
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000009201

Other devices from Joimax GmbH

See all devices from Joimax GmbH →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • 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
  • Serial Number: No
  • Expiration Date: No