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Aesculap FB167R

by Aesculap, Inc.

Part of a family of 32 devices: see the family page

Ref FB167R

Aesculap FB167R is a Class I device made by Aesculap, Inc., registered in EUDAMED on 2 Sep 2025 (Basic UDI-DI 40392390000006632M) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04038653043040), 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 Number40392390000006632M Basic UDI-DI 04038653043040UDI-DIDate2 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653043040 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000006632M registered 2 Sep 2025 Active
  • FDA GUDID UDI-DI 04038653043040 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653043040
  2. Registered EUDAMED 40392390000006632M

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  • Withdrawn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
Vascular dilator, reusable
Device name
Vessel dilator
Model / Ref / Catalog
FB167R
Primary DI / UDI-DI
04038653043040
Basic UDI-DI
40392390000006632M
FDA product code
FSM
EMDN code
L070802 Vascular dilators, reusable
GMDN term
Vascular dilator, 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 CARDIOVASCULAR SURGERY INSTRUMENTS, REUSABLE.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)