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Adapter Vario 077.0105

by Medela AG

Ref 077.0105

Adapter Vario 077.0105 is a device classified as Class I in the EU and Class II in the US made by Medela AG, registered in EUDAMED on 12 Aug 2026 (Basic UDI-DI 07612367ulhwydTA), cleared under FDA 510(k) K153663 on 18 May 2016 and listed in FDA GUDID since 3 Oct 2016 (UDI-DI 07612367015387), active as of 12 Nov 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153663

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07612367ulhwydTA Basic UDI-DI 07612367015387UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07612367015387 UDI-DI Date3 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153663 Date18 May 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 07612367ulhwydTA registered 12 Aug 2026 Active
  • FDA 510(k) K153663 decided 18 May 2016 Active
  • FDA GUDID UDI-DI 07612367015387 listed 3 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153663
  2. Listed FDA GUDID 07612367015387
  3. Registered EUDAMED 07612367ulhwydTA

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  • Withdrawn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

Trade name
Adapter Vario
Generic name
Desk mount
Device name
Vario Accessories
Model / reference
077.0105
Primary DI / UDI-DI
07612367015387
Basic UDI-DI
07612367ulhwydTA
510(k) Number
FDA product code
BTA
EMDN code
Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
GMDN term
Desk mount
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Standard device
EU market of registration
Germany
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.

Related devices

Category: Desk mount

Cleared under the same submission (K153663)

and 8 more cleared under K153663

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES.

Other devices from Medela AG

See all devices from Medela AG →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)