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Gimmi AY.1463.09

by Gimmi GmbH

Ref AY.1463.09

Gimmi AY.1463.09 is a device classified as Class IIa in the EU and Class I in the US made by Gimmi GmbH, registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI B-04049047677123) and listed in FDA GUDID since 6 May 2025 (UDI-DI 04049047677123), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-04049047677123 Basic UDI-DI 04049047677123UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049047677123 UDI-DI Date6 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04049047677123 registered 15 Sep 2026 Active
  • FDA GUDID UDI-DI 04049047677123 listed 6 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049047677123
  2. Registered EUDAMED B-04049047677123

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Gimmi
Generic name
Surgical/emergency suction cannula, non-illuminating, reusable
Model / Ref / Catalog
AY.1463.09
Description
FRAZIER SUCTION TUBE 45°, 9 CH. WORKING LENGTH 160 MM
Primary DI / UDI-DI
04049047677123
Basic UDI-DI
B-04049047677123
FDA product code
GEA
EMDN code
L030101 Suction and irrigation surgical cannulas and handpieces, reusable
GMDN term
Surgical/emergency suction cannula, non-illuminating, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
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: Surgical/emergency suction cannula, non-illuminating, reusable

Similar devices in this category

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

Other devices from Gimmi GmbH

See all devices from Gimmi GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)