Skip to content

Aesculap OM660R

by Aesculap, Inc.

Part of a family of 16 devices: see the family page

Ref OM660R

Aesculap OM660R is a Class I device made by Aesculap, Inc., registered in EUDAMED on 8 Oct 2025 (Basic UDI-DI 403923900000033623) and listed in FDA GUDID since 22 Apr 2020 (UDI-DI 04038653179985), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number403923900000033623 Basic UDI-DI 04038653179985UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653179985 UDI-DI Date22 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 403923900000033623 registered 8 Oct 2025 Active
  • FDA GUDID UDI-DI 04038653179985 listed 22 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653179985
  2. Registered EUDAMED 403923900000033623

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  • Withdrawn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
Aesculap
Generic name
Open-surgery dissector
Model / Ref / Catalog
OM660R
Primary DI / UDI-DI
04038653179985
Basic UDI-DI
403923900000033623
Direct marketing DI
04038653179985
FDA product code
KBM
EMDN code
L149099 ENT instruments, reusable - other
GMDN term
Open-surgery dissector
Device class
Class I
Regulation number
874.4420
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: Open-surgery dissector

Similar devices in this category

Other devices filed under ENT INSTRUMENTS, REUSABLE - OTHER.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

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