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Gyrus ACMI 890205

by Gyrus Acmi, Inc.

Ref 890205

Gyrus ACMI 890205 is a device classified as Class IIa in the EU and Class I in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI B-00821925022034) and listed in FDA GUDID since 13 Sep 2018 (UDI-DI 00821925022034), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925022034 Basic UDI-DI 00821925022034UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925022034 UDI-DI Date13 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00821925022034 registered 29 Sep 2026 Active
  • FDA GUDID UDI-DI 00821925022034 listed 13 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00821925022034
  2. Registered EUDAMED B-00821925022034

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  • Withdrawn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
Gyrus ACMI
Generic name
Tympanostomy tube
Device name
890205
Model / reference
890205
Primary DI / UDI-DI
00821925022034 EUDAMED
00821925034242 GUDID
Basic UDI-DI
B-00821925022034
FDA product code
LRC
EMDN code
Q030399 Instruments for ENT surgery, single-use - other
GMDN term
Tympanostomy tube
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
874.4420
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925022034
GUDID
00821925034242
Device classEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925022034; FDA GUDID lists 00821925034242), so their flags are not compared. 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: Tympanostomy tube

Similar devices in this category

Other devices filed under INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)