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handle for bipolar sizing shell 79606000

by implantcast GmbH

Ref 79606000Model HC13AHBIPINST

handle for bipolar sizing shell 79606000 is a Class I device made by implantcast GmbH, registered in EUDAMED on 29 Jul 2026 (Basic UDI-DI 4048844HC13AHBIPINSTSB) and listed in FDA GUDID since 26 Aug 2022 (UDI-DI 04048844067144), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844HC13AHBIPINSTSB Basic UDI-DI 04048844067144UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844067144 UDI-DI Date26 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844HC13AHBIPINSTSB registered 29 Jul 2026 Active
  • FDA GUDID UDI-DI 04048844067144 listed 26 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844067144
  2. Registered EUDAMED 4048844HC13AHBIPINSTSB

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  • Withdrawn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
handle for bipolar sizing shell
Generic name
Surgical instrument handle, non-torque-limiting
Model / reference
79606000, HC13AHBIPINST
Primary DI / UDI-DI
04048844067144
Basic UDI-DI
4048844HC13AHBIPINSTSB
Direct marketing DI
04048844067144
FDA product code
LXH
EMDN code
L030199 General surgery surgical cannulas and handpieces, reusable - other
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
Austria
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 GENERAL SURGERY SURGICAL CANNULAS AND HANDPIECES, REUSABLE - OTHER.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)