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Aesculap OB513

by Aesculap AG

Ref OB513

Aesculap OB513 is a Class I device made by Aesculap AG, registered in EUDAMED on 2 Sep 2025 (Basic UDI-DI 40392390000006702J) and listed in FDA GUDID since 6 May 2020 (UDI-DI 04038653175598), 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 Number40392390000006702J Basic UDI-DI 04038653175598UDI-DIDate2 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653175598 UDI-DI Date6 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000006702J registered 2 Sep 2025 Active
  • FDA GUDID UDI-DI 04038653175598 listed 6 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653175598
  2. Registered EUDAMED 40392390000006702J

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  • Withdrawn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
Ophthalmic surgical probe, reusable
Device name
Ophthalmology probe
Model / Ref / Catalog
OB513
Primary DI / UDI-DI
04038653175598
Basic UDI-DI
40392390000006702J
Direct marketing DI
04038653175598
FDA product code
MDM
EMDN code
L1705 Ophthalmology probes, reusable
GMDN term
Ophthalmic surgical probe, 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 OPHTHALMOLOGY PROBES, REUSABLE.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)