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Hsiner 1

by Hsiner Co., Ltd. 10 variants

Ref 30300

Hsiner 1 (30300) 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 5 Nov 2026 (Basic UDI-DI B-04719892367868) and listed in FDA GUDID since 21 May 2026 (UDI-DI 04712688053822), 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-04719892367868 Basic UDI-DI Date5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04712688053822 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04719892367868 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 04712688053822 listed 21 May 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04712688053822
  2. Registered EUDAMED B-04719892367868

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  • Withdrawn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
Oxygen administration tubing
Device name
Oxygen Tubing
Model / Ref / Catalog
30300, 1
Primary DI / UDI-DI
04712688053822, 04719892367868
Basic UDI-DI
B-04719892367868, B-04712688053822
FDA product code
BYX
EMDN code
R03010204 Oxygen administration tubings
GMDN term
Oxygen administration tubing
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5860
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
Greece
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
30300
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.

Similar devices in this category

Other devices filed under OXYGEN ADMINISTRATION TUBINGS.

Other devices from Hsiner Co., Ltd.

See all devices from Hsiner Co., Ltd. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)