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Aveta Controller

by Meditrina, Inc.

Ref 212-080

Aveta Controller (212-080) is a device classified as Class IIb in the EU and Class II in the US made by Meditrina, Inc., registered in EUDAMED on 10 Jul 2024 (Basic UDI-DI 00850006759019D2), cleared under FDA 510(k) K190372 on 16 May 2019 and listed in FDA GUDID since 26 Nov 2019 (UDI-DI 00850006759019), 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 Number00850006759019D2 Basic UDI-DI 00850006759019UDI-DIDate10 Jul 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00850006759019 UDI-DI Date26 Nov 2019ListedStatusListed 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 00850006759019D2 registered 10 Jul 2024 Active
  • FDA 510(k) K190372 decided 16 May 2019 Active
  • FDA GUDID UDI-DI 00850006759019 listed 26 Nov 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190372
  2. Listed FDA GUDID 00850006759019
  3. Registered EUDAMED 00850006759019D2

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  • Withdrawn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
Hysteroscopic irrigation/insufflation system
Model / Ref / Catalog
212-080
Primary DI / UDI-DI
00850006759019
Basic UDI-DI
00850006759019D2
Direct marketing DI
00850006759019
510(k) Number
FDA product code
HIG, HIH
EMDN code
Z12080203 Hysterosuction surgical aspirators
GMDN term
Hysteroscopic irrigation/insufflation system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
884.1700, 884.1690
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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

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Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)