Skip to content

EndoEar™ SUCTION 1.85.03

by Grace Medical, Inc.

Part of a family of 43 devices: see the family page

Ref 1.85.03Model Suction Instrument

EndoEar™ SUCTION 1.85.03 is a device classified as Class IIa in the EU and Class I in the US made by Grace Medical, Inc., registered in EUDAMED on 18 May 2026 (Basic UDI-DI 08445050023LG) and listed in FDA GUDID since 17 Aug 2020 (UDI-DI 00844505012133), 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 Number08445050023LG Basic UDI-DI 00844505012133UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00844505012133 UDI-DI Date17 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08445050023LG registered 18 May 2026 Active
  • FDA GUDID UDI-DI 00844505012133 listed 17 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00844505012133
  2. Registered EUDAMED 08445050023LG

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  • Withdrawn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
EndoEar™ SUCTION LONG CURVE, 3 FR, UP STAINLESS STEEL EUDAMED
EndoEar™ SUCTION GUDID
Generic name
Surgical/emergency suction cannula, non-illuminating, reusable
Model / reference
1.85.03, Suction Instrument
Primary DI / UDI-DI
00844505012133
Basic UDI-DI
08445050023LG
Direct marketing DI
00844505012133
FDA product code
JZF
EMDN code
L14050199 Middle ear surgery instruments, reusable - other
GMDN term
Surgical/emergency suction cannula, non-illuminating, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
874.4420
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: Surgical/emergency suction cannula, non-illuminating, reusable

Similar devices in this category

Other devices filed under MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Grace Medical, Inc.

See all devices from Grace Medical, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)