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Aesculap OG161R

by Aesculap, Inc.

Ref OG161R

Aesculap OG161R is a Class I device made by Aesculap, Inc., registered in EUDAMED on 8 Oct 2025 (Basic UDI-DI 40392390000003932F) and listed in FDA GUDID since 23 Apr 2020 (UDI-DI 04038653207312), 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 Number40392390000003932F Basic UDI-DI 04038653207312UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653207312 UDI-DI Date23 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000003932F registered 8 Oct 2025 Active
  • FDA GUDID UDI-DI 04038653207312 listed 23 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653207312
  2. Registered EUDAMED 40392390000003932F

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  • Withdrawn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
Bone file/rasp, manual, reusable
Device name
Raspatorien
Model / Ref / Catalog
OG161R
Primary DI / UDI-DI
04038653207312
Basic UDI-DI
40392390000003932F
FDA product code
HTR
EMDN code
L14050102 Ossicular surgery rasps and files, reusable
GMDN term
Bone file/rasp, manual, reusable
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

Similar devices in this category

Other devices filed under MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE.

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Properties

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