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Aesculap BB178R

by Aesculap, Inc.

Part of a family of 37 devices: see the family page

Ref BB178R

Aesculap BB178R is a Class I device made by Aesculap, Inc., registered in EUDAMED on 8 Oct 2025 (Basic UDI-DI 4039239000000403ZN) and listed in FDA GUDID since 23 Apr 2020 (UDI-DI 04046963103842), 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 Number4039239000000403ZN Basic UDI-DI 04046963103842UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046963103842 UDI-DI Date23 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4039239000000403ZN registered 8 Oct 2025 Active
  • FDA GUDID UDI-DI 04046963103842 listed 23 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046963103842
  2. Registered EUDAMED 4039239000000403ZN

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  • Withdrawn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
Scalpel handle, reusable
Device name
Scalpel
Model / Ref / Catalog
BB178R
Primary DI / UDI-DI
04046963103842
Basic UDI-DI
4039239000000403ZN
Direct marketing DI
04046963103842
FDA product code
GDZ
EMDN code
L010103 Handles for scalpels, reusable
GMDN term
Scalpel handle, 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 HANDLES FOR SCALPELS, 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)