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Demax DHD30P/OFF

by Beijing Demax Medical Technology Co., Ltd.

Part of a family of 8 devices: see the family page

Ref DHD30P/OFFModel DMKIDS30S

Demax DHD30P/OFF is a device classified as Class I in the EU and Class II in the US made by Beijing Demax Medical Technology Co., Ltd., registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI 69437182MastroRFSWY), cleared under FDA 510(k) K140943 on 5 Mar 2015 and listed in FDA GUDID since 12 Sep 2022 (UDI-DI 06943718223290), active as of 25 Oct 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140943

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69437182MastroRFSWY Basic UDI-DI 06943718223290UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06943718223290 UDI-DI Date12 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140943 Date5 Mar 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69437182MastroRFSWY registered 24 Jul 2026 Active
  • FDA 510(k) K140943 decided 5 Mar 2015 Active
  • FDA GUDID UDI-DI 06943718223290 listed 12 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140943
  2. Listed FDA GUDID 06943718223290
  3. Registered EUDAMED 69437182MastroRFSWY

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  • Withdrawn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
Demax
Generic name
Catheter/overtube balloon inflator, single-use
Device name
Balloon In-deflation Device
Model / reference
DHD30P/OFF, DMKIDS30S
Primary DI / UDI-DI
06943718223290
Basic UDI-DI
69437182MastroRFSWY
510(k) Number
FDA product code
MAV
EMDN code
C01040180 Coronary angiography devices - accessories not included in other classes
GMDN term
Catheter/overtube balloon inflator, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1650
EU registration type
Standard device
EU market of registration
Czechia
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: Catheter/overtube balloon inflator, single-use

Cleared under the same submission (K140943)

and 8 more cleared under K140943

Similar devices in this category

Other devices filed under CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from Beijing Demax Medical Technology Co., Ltd.

See all devices from Beijing Demax Medical Technology Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • HCT/P
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)