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Vygon 5534.91

by Vygon

Ref 5534.91

Vygon 5534.91 is a Class I device made by Vygon, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-03660812019101) and listed in FDA GUDID since 28 Feb 2018 (UDI-DI 03660812019101), 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-03660812019101 Basic UDI-DI 03660812019101UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03660812019101 UDI-DI Date28 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03660812019101 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 03660812019101 listed 28 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03660812019101
  2. Registered EUDAMED B-03660812019101

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  • Withdrawn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
Mucus extractor - 35ml EUDAMED
Vygon GUDID
Generic name
General specimen container IVD, no additive, sterile
Model / Ref / Catalog
5534.91
Primary DI / UDI-DI
03660812019101
Basic UDI-DI
B-03660812019101
FDA product code
BSY
EMDN code
R05010301 Single-chamber mucous membrane aspirators
GMDN term
General specimen container IVD, no additive, sterile
Device class
Class I
Regulation number
868.6810
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: General specimen container IVD, no additive, sterile

Similar devices in this category

Other devices filed under SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS.

Other devices from Vygon

See all devices from Vygon →

Properties

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