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Endo-Chisel TEC155020L

by Joimax, Inc.

Ref TEC155020L

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
European UnionCE/MDR EUDAMED Number42503371ABLACUR6H Basic UDI-DI 04250337120568UDI-DIDate29 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337120568 UDI-DI Date29 Sep 2023ListedStatusListed 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Endo-Chisel, with handle EUDAMED
Endo-Chisel GUDID
Generic Name
Orthopaedic chisel
Device Name
Curette
Model / Ref / Catalog
TEC155020L
Primary DI / UDI-DI
04250337120568
Basic UDI-DI
42503371ABLACUR6H
Direct Marketing DI
04250337120568
FDA Product Code
FZS
EMDN Code
L1113 Neurosurgery burs and tips, reusable
GMDN Term
Orthopaedic chisel
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic chisel

Other devices from Joimax, Inc.

See all devices from Joimax, Inc. →

Properties

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

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: 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