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ball-handle BHR4137

by Joimax, Inc.

Ref BHR4137

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42503371REAMHDQ Basic UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337108306 UDI-DIDate30 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ball Handle for Reamer EUDAMED
ball-handle GUDID
Generic Name
Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog
BHR4137
Primary DI / UDI-DI
04250337108306
Basic UDI-DI
42503371REAMHDQ
Direct Marketing DI
04250337108306
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
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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