Docking Station 079.0037: CE/MDR Class I, Medela LLC

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number07612367tlwvftV8 Basic UDI-DI 07612367024426UDI-DI	Date29 Jun 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK172145	Date9 May 2018Decided	StatusActive
United States	GUDID listing GUDID	Number07612367024426 UDI-DI	Date3 Oct 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK142626	Date12 Jun 2015Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK141553	Date25 Aug 2014Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 07612367tlwvftV8 — open Devices and search for it
AccessGUDID record UDI-DI 07612367024426
FDA 510(k) database 510(k) number K172145
FDA 510(k) database 510(k) number K142626
FDA 510(k) database 510(k) number K141553

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 07612367tlwvftV8 registered 29 Jun 2026 Active
FDA 510(k) K172145 decided 9 May 2018 Active· +2 more in the status table
FDA GUDID UDI-DI 07612367024426 listed 3 Oct 2016 Listed

Timeline

5 dated events

25 Aug 2014 Cleared FDA 510(k) K141553
12 Jun 2015 Cleared FDA 510(k) K142626
3 Oct 2016 Listed FDA GUDID 07612367024426
9 May 2018 Cleared FDA 510(k) K172145
29 Jun 2026 Registered EUDAMED 07612367tlwvftV8

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: Docking Station
Generic name: Noninvasive device battery charger
Device name: Thopaz+ Invia Liberty Accessories
Model / reference: 079.0037

Primary DI / UDI-DI: 07612367024426
Basic UDI-DI: 07612367tlwvftV8
510(k) Number: K141553
K142626
K172145
FDA product code: OMP, BTA
EMDN code: A0680 Drainage and fluid collection devices - accessories
GMDN term: Noninvasive device battery charger

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

Field	EUDAMED	GUDID
Device class	EUDAMED 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.