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Gyrus Acmi 130699

by Gyrus Acmi, Inc.

Ref 130699

Gyrus Acmi 130699 is an ear speculum (EU MDD Class I; FDA Class I; FDA product code EPY, Speculum, Ent) made by Gyrus Acmi, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00821925014442) and listed in FDA GUDID since 4 Sep 2018 (UDI-DI 00821925014442), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925014442 Basic UDI-DI 00821925014442UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925014442 UDI-DI Date4 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00821925014442 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00821925014442 listed 4 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00821925014442
  2. Registered EUDAMED B-00821925014442

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  • Withdrawn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
Ear speculum, single-use
Device name
130699
Model / reference
130699
Primary DI / UDI-DI
00821925014442 EUDAMED
00821925033290 GUDID
Basic UDI-DI
B-00821925014442
FDA product code
EPY
EMDN code
Q030499 Otology devices - other
GMDN term
Ear speculum, single-use
Device class
Class I
Regulation number
878.1800
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 · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925014442
GUDID
00821925033290
Sterilise before useEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925014442; FDA GUDID lists 00821925033290), so their flags are not compared.

Related devices

Category: Ear speculum, single-use

Similar devices in this category

Other devices filed under OTOLOGY DEVICES - OTHER.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)