Skip to content

Thopaz+

by Medela AG 3 variants

Ref 079.1002

Thopaz+ (200.5718) is a device classified as Class IIb in the EU and Class II in the US made by Medela AG, registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI 07612367jnkvtcPG), cleared under FDA 510(k) K141553 on 25 Aug 2014 and listed in FDA GUDID since 3 Oct 2016 (UDI-DI 07612367043298), 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) K141553

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 Number07612367jnkvtcPG Basic UDI-DI 07612367043298UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07612367043298 UDI-DI Date3 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK141553 Date25 Aug 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 07612367jnkvtcPG registered 24 Jun 2026 Active
  • FDA 510(k) K141553 decided 25 Aug 2014 Active
  • FDA GUDID UDI-DI 07612367043298 listed 3 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K141553
  2. Listed FDA GUDID 07612367043298
  3. Registered EUDAMED 07612367jnkvtcPG

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  • Withdrawn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
Thoracic suction pump
Device name
Thopaz +
Model / Ref / Catalog
079.1002 EUDAMED
Thopaz+ GUDID
200.5718 GUDID
Description
Thoracic suction system pump 079.1002
Primary DI / UDI-DI
07612367043298
Basic UDI-DI
07612367jnkvtcPG
Direct marketing DI
07612367089265
510(k) Number
FDA product code
BTA
EMDN code
A060199 Surgical drainage systems - other
GMDN term
Thoracic suction pump
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
079.1002
GUDID
Thopaz+
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.

Related devices

Category: Thoracic suction pump

Cleared under the same submission (K141553)

and 8 more cleared under K141553

Similar devices in this category

Other devices filed under SURGICAL DRAINAGE SYSTEMS - OTHER.

Other devices from Medela AG

See all devices from Medela AG →

Properties

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