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Demax DMK-T-01(ON)

by Beijing Demax Medical Technology Co., Ltd.

Ref DMK-T-01（ON）

Demax DMK-T-01(ON) is a device classified as Class IIa in the EU and Class II in the US made by Beijing Demax Medical Technology Co., Ltd., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 69437182DM12W) and listed in FDA GUDID since 26 Jul 2022 (UDI-DI 06943718202011), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69437182DM12W Basic UDI-DI 06943718202011UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06943718202011 UDI-DI Date26 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69437182DM12W registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 06943718202011 listed 26 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06943718202011
  2. Registered EUDAMED 69437182DM12W

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Demax
Generic name
Stopcock
Device name
Manifolds
Model / reference
DMK-T-01（ON） EUDAMED
DMK-T-01(ON) GUDID
Primary DI / UDI-DI
06943718202011
Basic UDI-DI
69437182DM12W
FDA product code
DTL
EMDN code
A0703 Stopcocks
GMDN term
Stopcock
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.4290
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
DMK-T-01（ON）
GUDID
DMK-T-01(ON)
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: Stopcock

Similar devices in this category

Other devices filed under STOPCOCKS.

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

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

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)