Skip to content

Bone Management

by Hager & Meisinger GmbH 164 variants

Ref HI070Model Hand-held instruments dentistry

Bone Management (HI070) is a Class I device made by Hager & Meisinger GmbH, registered in EUDAMED on 19 May 2025 (Basic UDI-DI ++E0HM352I05AEQN) and listed in FDA GUDID since 15 Sep 2021 (UDI-DI E0HM39HI0701), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E0HM352I05AEQN Basic UDI-DI E0HM39HI0701UDI-DIDate19 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberE0HM39HI0701 UDI-DI Date15 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E0HM352I05AEQN registered 19 May 2025 Active
  • FDA GUDID UDI-DI E0HM39HI0701 listed 15 Sep 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID E0HM39HI0701
  2. Registered EUDAMED ++E0HM352I05AEQN

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  • Withdrawn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

Generic name
Surgical mallet
Model / Ref / Catalog
Hand-held instruments dentistry, HI070
Primary DI / UDI-DI
E0HM39HI0701
Basic UDI-DI
++E0HM352I05AEQN
Direct marketing DI
E0HM39HI0701
FDA product code
HWM
EMDN code
Q0199 Odontology devices - other
GMDN term
Surgical mallet
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
DE-MF-000004966

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Hager & Meisinger GmbH

See all devices from Hager & Meisinger GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)