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Aesculap BB046R

by Aesculap, Inc.

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

Ref BB046R

Aesculap BB046R 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 21 Apr 2020 (UDI-DI 04038653137398), 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 Number4039239000000403ZN Basic UDI-DI 04038653137398UDI-DIDate8 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653137398 UDI-DI Date21 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 04038653137398 listed 21 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653137398
  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  • Withdrawn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
BB046R
Primary DI / UDI-DI
04038653137398
Basic UDI-DI
4039239000000403ZN
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

Related devices

Category: Scalpel handle, reusable

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)