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Aesculap FB153R

by Aesculap AG

Part of a family of 66 devices: see the family page

Ref FB153R

Aesculap FB153R is a device classified as Class IIa in the EU and Class I in the US made by Aesculap AG, registered in EUDAMED on 18 Nov 2025 (Basic UDI-DI 40392390000005832N) and listed in FDA GUDID since 17 Jun 2020 (UDI-DI 04038653419456), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000005832N Basic UDI-DI 04038653419456UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653419456 UDI-DI Date17 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000005832N registered 18 Nov 2025 Active
  • FDA GUDID UDI-DI 04038653419456 listed 17 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653419456
  2. Registered EUDAMED 40392390000005832N

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  • Withdrawn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
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Device name
Suction and irrigation instruments IIa
Model / Ref / Catalog
FB153R
Primary DI / UDI-DI
04038653419456
Basic UDI-DI
40392390000005832N
FDA product code
GEA
EMDN code
L030101 Suction and irrigation surgical cannulas and handpieces, reusable
GMDN term
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Device class
Class IIa EUDAMED
Class I GUDID
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

Similar devices in this category

Other devices filed under SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE.

Other devices from Aesculap AG

See all devices from Aesculap AG →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)