Skip to content

devemed 2815-50

by devemed GmbH

Part of a family of 94 devices: see the family page

Ref 2815-50

devemed 2815-50 is a Class I device made by devemed GmbH, registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI 4061644PG01040223) and listed in FDA GUDID since 15 Apr 2020 (UDI-DI 04061644020096), 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 Number4061644PG01040223 Basic UDI-DI 04061644020096UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04061644020096 UDI-DI Date15 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4061644PG01040223 registered 8 Jul 2026 Active
  • FDA GUDID UDI-DI 04061644020096 listed 15 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04061644020096
  2. Registered EUDAMED 4061644PG01040223

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  • Withdrawn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
devemed
Generic name
Dental osteotome
Device name
Osteotomes
Model / reference
2815-50
Description
Bone pusher-Attachment "Palti" straight, 5.0 mm
Primary DI / UDI-DI
04061644020096
Basic UDI-DI
4061644PG01040223
Direct marketing DI
04061644020096
FDA product code
EMM
EMDN code
L150101 Odontostomatology osteotomes, reusable
GMDN term
Dental osteotome
Device class
Class I
Regulation number
872.4565
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: Dental osteotome

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY OSTEOTOMES, REUSABLE.

Other devices from devemed GmbH

See all devices from devemed GmbH →

Properties

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