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Aesculap FB375R

by Aesculap, Inc.

Part of a family of 62 devices: see the family page

Ref FB375R

Aesculap FB375R is a device classified as Class I in the EU and Class II in the US made by Aesculap, Inc., registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI 40392390000004552C) and listed in FDA GUDID since 14 Oct 2020 (UDI-DI 04046963458560), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000004552C Basic UDI-DI 04046963458560UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04046963458560 UDI-DI Date14 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000004552C registered 22 Sep 2026 Active
  • FDA GUDID UDI-DI 04046963458560 listed 14 Oct 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046963458560
  2. Registered EUDAMED 40392390000004552C

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  • Withdrawn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
Atraumata® EUDAMED
Aesculap GUDID
Generic name
Surgical bulldog clamp, reusable
Model / Ref / Catalog
FB375R
Primary DI / UDI-DI
04046963458560
Basic UDI-DI
40392390000004552C
Direct marketing DI
04046963458560
FDA product code
DXC
EMDN code
L0708010101 Bulldog vascular clips, reusable
GMDN term
Surgical bulldog clamp, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.4450
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.

Related devices

Category: Surgical bulldog clamp, reusable

Similar devices in this category

Other devices filed under CARDIOVASCULAR 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)