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Ergoplant

by Aesculap AG 65 variants

Ref DX506T

Ergoplant (DX506T) is a Class I device made by Aesculap AG, registered in EUDAMED on 16 Sep 2025 (Basic UDI-DI 4039239000000511ZS) and listed in FDA GUDID since 7 Jul 2020 (UDI-DI 04046963322229), 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 Number4039239000000511ZS Basic UDI-DI 04046963322229UDI-DIDate16 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046963322229 UDI-DI Date7 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4039239000000511ZS registered 16 Sep 2025 Active
  • FDA GUDID UDI-DI 04046963322229 listed 7 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046963322229
  2. Registered EUDAMED 4039239000000511ZS

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  • Withdrawn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
Hand-held dental retractor
Device name
Bone Split instrument dental
Model / Ref / Catalog
DX506T
Primary DI / UDI-DI
04046963322229
Basic UDI-DI
4039239000000511ZS
FDA product code
EIG
EMDN code
L150201 Dental retractors, reusable
GMDN term
Hand-held dental retractor
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

Manufacturer details

EUDAMED SRN
DE-MF-000005504

Similar devices in this category

Other devices filed under DENTAL RETRACTORS, REUSABLE.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

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