Skip to content

ATMOS S 201 Thorax

by ATMOS MedizinTechnik GmbH & Co. KG

Ref 312.1000.0Model Suction unit, thoracic

ATMOS S 201 Thorax (312.1000.0) is a thoracic suction pump (EU MDD Class IIa; FDA Class II; FDA product code BTA, Pump, Portable, Aspiration (Manual Or Powered)) made by ATMOS MedizinTechnik GmbH & Co. KG, registered in EUDAMED on 22 May 2026 (Basic UDI-DI B-04250365132304), cleared under FDA 510(k) K103042 on 15 Apr 2011 and listed in FDA GUDID since 14 Jul 2023 (UDI-DI 04250365132304), active as of 24 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103042

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250365132304 Basic UDI-DI 04250365132304UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250365132304 UDI-DI Date14 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103042 Date15 Apr 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04250365132304 registered 22 May 2026 Active
  • FDA 510(k) K103042 decided 15 Apr 2011 Active
  • FDA GUDID UDI-DI 04250365132304 listed 14 Jul 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103042
  2. Listed FDA GUDID 04250365132304
  3. Registered EUDAMED B-04250365132304

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ATMOS S 201 Thorax EUDAMED
Atmos GUDID
Generic name
Thoracic suction pump
Model / Ref / Catalog
Suction unit, thoracic, 312.1000.0, S 201 Thorax
Primary DI / UDI-DI
04250365132304
Basic UDI-DI
B-04250365132304
510(k) Number
FDA product code
BTA
EMDN code
A0601010201 Drainage systems with adjustable suction and collection chamber
GMDN term
Thoracic suction pump
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4780
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Suction unit, thoracic
312.1000.0
GUDID
S 201 Thorax
Device classEUDAMED
Class IIa
GUDID
Class II

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

Similar devices in this category

Other devices filed under DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER.

Other devices from ATMOS MedizinTechnik GmbH & Co. KG

Properties

  • Administering medicine
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)