Skip to content

n/a E1005

by Hager & Meisinger Gesellschaft mit beschränkter Haftung

Ref E1005Model Surgical hand-held instruments

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E0HM209I04ABPW Basic UDI-DI E0HM39E10051UDI-DIDate19 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberE0HM39E10051 UDI-DI Date15 Sep 2021ListedStatusListed 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  • Withdrawn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
Bone Management
Generic Name
Dental osteotome
Model / Ref / Catalog
E1005, Surgical hand-held instruments
Primary DI / UDI-DI
E0HM39E10051
Basic UDI-DI
++E0HM209I04ABPW
FDA Product Code
GFF
EMDN Code
Q0199 Odontology devices - other
GMDN Term
Dental osteotome
Device Class
Class I
Regulation Number
878.4820
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Dental osteotome

Other devices from Hager & Meisinger Gesellschaft mit beschränkter Haftung

See all devices from Hager & Meisinger Gesellschaft mit beschränkter Haftung →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Manufacturing Date: No