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Aesculap OF262R

by Aesculap AG

Part of a family of 14 devices: see the family page

Ref OF262R

Aesculap OF262R is a Class I device made by Aesculap AG, registered in EUDAMED on 13 Oct 2025 (Basic UDI-DI 40392390000005942T) and listed in FDA GUDID since 22 Apr 2020 (UDI-DI 04038653176304), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000005942T Basic UDI-DI 04038653176304UDI-DIDate13 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653176304 UDI-DI Date22 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000005942T registered 13 Oct 2025 Active
  • FDA GUDID UDI-DI 04038653176304 listed 22 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653176304
  2. Registered EUDAMED 40392390000005942T

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  • Withdrawn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
General-purpose absorbent tip applicator/swab, reusable
Device name
Cotton applicator
Model / Ref / Catalog
OF262R
Primary DI / UDI-DI
04038653176304
Basic UDI-DI
40392390000005942T
FDA product code
KCJ
EMDN code
L149005 ENT probes, reusable
GMDN term
General-purpose absorbent tip applicator/swab, reusable
Device class
Class I
Regulation number
874.5220
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 ENT PROBES, REUSABLE.

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Properties

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