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Demax DHDY01B

by Beijing Demax Medical Technology Co., Ltd.

Ref DHDY01BModel DRY01B

Demax DHDY01B 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 20 Sep 2026 (Basic UDI-DI 69437182TwistYtiDP) and listed in FDA GUDID since 14 Jul 2022 (UDI-DI 06943718265085), 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 Number69437182TwistYtiDP Basic UDI-DI 06943718265085UDI-DIDate20 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06943718265085 UDI-DI Date14 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69437182TwistYtiDP registered 20 Sep 2026 Active
  • FDA GUDID UDI-DI 06943718265085 listed 14 Jul 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06943718265085
  2. Registered EUDAMED 69437182TwistYtiDP

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  • Withdrawn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
Haemostasis valve
Device name
Twist Y Connector Kit
Model / reference
DHDY01B, DRY01B
Primary DI / UDI-DI
06943718265085
Basic UDI-DI
69437182TwistYtiDP
FDA product code
DTL
EMDN code
C900101 Haemostasis valves
GMDN term
Haemostasis valve
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.4290
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
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: Haemostasis valve

Similar devices in this category

Other devices filed under HAEMOSTASIS VALVES.

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)