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Tessys® RHC108590

by Joimax, Inc.

Ref RHC108590

Tessys® RHC108590 is a Class I device made by Joimax, Inc., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 42503371REAMHDQ) and listed in FDA GUDID since 30 Dec 2022 (UDI-DI 04250337105428), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503371REAMHDQ Basic UDI-DI 04250337105428UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337105428 UDI-DI Date30 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 42503371REAMHDQ registered 21 May 2026 Active
  • FDA GUDID UDI-DI 04250337105428 listed 30 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250337105428
  2. Registered EUDAMED 42503371REAMHDQ

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  • Withdrawn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
TESSYS® Reamer Handle XT, cannulated EUDAMED
Tessys® GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Ball Handle for Reamer
Model / Ref / Catalog
RHC108590
Primary DI / UDI-DI
04250337105428
Basic UDI-DI
42503371REAMHDQ
FDA product code
HTO
EMDN code
L80 Surgical instruments, reusable - various accessories
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical instrument handle, non-torque-limiting

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES.

Other devices from Joimax, Inc.

See all devices from Joimax, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)