Skip to content

Aesculap

by Aesculap AG 1,000+ variants

Ref OK103R

Aesculap (OK103R) is a Class I device made by Aesculap AG, registered in EUDAMED on 14 Jul 2025 (Basic UDI-DI 4039239000000405ZS) and listed in FDA GUDID since 6 Jul 2020 (UDI-DI 04038653177110), 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 Number4039239000000405ZS Basic UDI-DI 04038653177110UDI-DIDate14 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653177110 UDI-DI Date6 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4039239000000405ZS registered 14 Jul 2025 Active
  • FDA GUDID UDI-DI 04038653177110 listed 6 Jul 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653177110
  2. Registered EUDAMED 4039239000000405ZS

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  • Withdrawn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
Nasal speculum, reusable
Device name
Speculum spreader
Model / Ref / Catalog
OK103R
Primary DI / UDI-DI
04038653177110
Basic UDI-DI
4039239000000405ZS
Direct marketing DI
04038653177110
FDA product code
KAL
EMDN code
L149004 ENT speculums, reusable
GMDN term
Nasal speculum, reusable
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

Manufacturer details

EUDAMED SRN
DE-MF-000005504

Similar devices in this category

Other devices filed under ENT SPECULUMS, REUSABLE.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)