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Aveta Opal Reusable Cable

by Meditrina, Inc.

Ref 220-2011

Aveta Opal Reusable Cable (220-2011) is a device classified as Class I in the EU and Class II in the US made by Meditrina, Inc., registered in EUDAMED on 2 Feb 2024 (Basic UDI-DI 00850006759583E4), cleared under FDA 510(k) K190372 on 16 May 2019 and listed in FDA GUDID since 23 Jun 2021 (UDI-DI 00850006759583), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190372

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00850006759583E4 Basic UDI-DI 00850006759583UDI-DIDate2 Feb 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00850006759583 UDI-DI Date23 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190372 Date16 May 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 00850006759583E4 registered 2 Feb 2024 Active
  • FDA 510(k) K190372 decided 16 May 2019 Active
  • FDA GUDID UDI-DI 00850006759583 listed 23 Jun 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190372
  2. Listed FDA GUDID 00850006759583
  3. Registered EUDAMED 00850006759583E4

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Electrical-only medical device connection cable, reusable
Model / Ref / Catalog
220-2011
Primary DI / UDI-DI
00850006759583
Basic UDI-DI
00850006759583E4
Direct marketing DI
00850006759583
510(k) Number
FDA product code
HIH, HIG
EMDN code
L0317 General surgery adapters and connectors, reusable
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.1690, 884.1700
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
US-MF-000033191
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE.

Other devices from Meditrina, Inc.

See all devices from Meditrina, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)