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Vygon 2595.30

by Vygon

Ref 2595.30

Vygon 2595.30 (00259530) is a device classified as Class IIa in the EU and Class I in the US made by Vygon, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-03660812125611) and listed in FDA GUDID since 30 Jun 2023 (UDI-DI 03660812125611), active as of 9 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03660812125611 Basic UDI-DI 03660812125611UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03660812125611 UDI-DI Date30 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03660812125611 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 03660812125611 listed 30 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03660812125611
  2. Registered EUDAMED B-03660812125611

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  • Withdrawn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
Nasal neonatal ventilation catheter in silicone - Ø 3.0 x 5.0 mm - 15Fr - L. 90 mm EUDAMED
Vygon GUDID
Generic name
Nasal oxygen cannula, CPAP
Model / Ref / Catalog
2595.30, 00259530
Primary DI / UDI-DI
03660812125611
Basic UDI-DI
B-03660812125611
FDA product code
CAT
EMDN code
R0301020301 Oxygen therapy standard nasal cannulas (goggles)
GMDN term
Nasal oxygen cannula, CPAP
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5340
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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, CPAP

Similar devices in this category

Other devices filed under OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES).

Other devices from Vygon

See all devices from Vygon →

Properties

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