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palm-handle TECH12121

by Joimax, Inc. EUDAMEDGUDID

Active European Union

Ref TECH12121

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503371REAMREAFD Basic UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337112877 UDI-DIDate30 Dec 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Multifunctional Palm Handle with Quick-Lock EUDAMED
palm-handle GUDID
Generic Name
Surgical instrument handle, non-torque-limiting
Device Name
CESSYS® Cervical Reamer
Model / Ref / Catalog
TECH12121
Primary DI / UDI-DI
04250337112877
Basic UDI-DI
42503371REAMREAFD
Direct Marketing DI
04250337112877
FDA Product Code
GEG
EMDN Code
L80 Surgical instruments, reusable - various accessories
GMDN Term
Surgical instrument handle, non-torque-limiting
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
Market of Registration
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

Related devices

Category: Surgical instrument handle, non-torque-limiting

Other devices from Joimax, Inc.

See all devices from Joimax, Inc. →

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