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Hsiner 1

by Hsiner Co., Ltd. 10 variants

Ref 14933

Hsiner 1 (14933) is a device classified as Class IIa in the EU and Class I in the US made by Hsiner Co., Ltd., registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-04711064681666) and listed in FDA GUDID since 2 Jul 2021 (UDI-DI 04711064681666), active as of 12 Nov 2026.

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

CE MDD

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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04711064681666 Basic UDI-DI 04711064681666UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04711064681666 UDI-DI Date2 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04711064681666 registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI 04711064681666 listed 2 Jul 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04711064681666
  2. Registered EUDAMED B-04711064681666

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Hsiner
Generic name
Nasal oxygen cannula, basic
Device name
Nasal Cannula
Model / Ref / Catalog
14933, 1
Primary DI / UDI-DI
04711064681666
Basic UDI-DI
B-04711064681666
FDA product code
CAT
EMDN code
R0301020302 High flow therapy nasal cannulas (hfnc)
GMDN term
Nasal oxygen cannula, basic
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5340
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
14933
GUDID
1
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Nasal oxygen cannula, basic

Similar devices in this category

Other devices filed under HIGH FLOW THERAPY NASAL CANNULAS (HFNC).

Other devices from Hsiner Co., Ltd.

See all devices from Hsiner Co., Ltd. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)