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Aesculap EB065R

by Aesculap, Inc.

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

Ref EB065R

Aesculap EB065R is a device classified as Class I in the EU and Class II in the US made by Aesculap, Inc., registered in EUDAMED on 2 Sep 2025 (Basic UDI-DI 40392390000004382C) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04038653039074), 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 Number40392390000004382C Basic UDI-DI 04038653039074UDI-DIDate2 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653039074 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000004382C registered 2 Sep 2025 Active
  • FDA GUDID UDI-DI 04038653039074 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653039074
  2. Registered EUDAMED 40392390000004382C

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  • Withdrawn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
Abdominal/ENT/orthopaedic surgical probe, reusable
Device name
Bile-duct dilator
Model / Ref / Catalog
EB065R
Primary DI / UDI-DI
04038653039074
Basic UDI-DI
40392390000004382C
Direct marketing DI
04038653039074
FDA product code
EZM
EMDN code
L04100101 Biliary surgical probes, reusable
GMDN term
Abdominal/ENT/orthopaedic surgical probe, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.5365
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under ABDOMINAL SURGERY INSTRUMENTS, REUSABLE.

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)