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C235

by EKOM spol. s r.o. 5 variants

Ref 430402B09-005Model C235

C235 is a device classified as Class IIb in the EU and Class II in the US made by EKOM spol. s r.o., registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI B-08586014620141), cleared under FDA 510(k) K091871 on 23 Oct 2009 and listed in FDA GUDID since 13 May 2016 (UDI-DI 08586014620141), active as of 9 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 9 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K091871

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Oct 2026.

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08586014620141 Basic UDI-DI 08586014620141UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08586014620141 UDI-DI Date13 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK091871 Date23 Oct 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08586014620141 registered 24 Jun 2026 Active
  • FDA 510(k) K091871 decided 23 Oct 2009 Active
  • FDA GUDID UDI-DI 08586014620141 listed 13 May 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K091871
  2. Listed FDA GUDID 08586014620141
  3. Registered EUDAMED B-08586014620141

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  • Withdrawn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

Generic name
Medical device air compressor
Device name
Medical compressor
Model / reference
C235, 430402B09-005
Primary DI / UDI-DI
08586014620141
Basic UDI-DI
B-08586014620141
510(k) Number
FDA product code
BTI
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Medical device air compressor
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.6250
EU registration type
Legacy device (under a directive)
EU market of registration
Slovakia
GUDID distribution status
In Commercial Distribution

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.

Related devices

Category: Medical device air compressor

Cleared under the same submission (K091871)

and 8 more cleared under K091871

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from EKOM spol. s r.o.

See all devices from EKOM spol. s r.o. →

Properties

  • Serial number
Other properties (22, all answered No)