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Expiratory valve set 950158

by Hamilton Medical AG

Ref 950158

Expiratory valve set 950158 is a Class I device made by Hamilton Medical AG, registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 76300028PN9501585S) and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 07630002805384), active as of 9 Nov 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300028PN9501585S Basic UDI-DI 07630002805384UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630002805384 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76300028PN9501585S registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 07630002805384 listed 8 Dec 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 07630002805384
  2. Registered EUDAMED 76300028PN9501585S

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  • Withdrawn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
Expiratory valve set for HAMILTON-G5/S1/GALILEO, single use EUDAMED
Expiratory valve set GUDID
Generic name
Mechanical expiratory valve, single-use
Model / reference
950158
Primary DI / UDI-DI
07630002805384
Basic UDI-DI
76300028PN9501585S
FDA product code
BYX
EMDN code
R9080 Respiratory and anesthesia devices - accessories not included in other classes
GMDN term
Mechanical expiratory valve, single-use
Device class
Class I
Regulation number
868.5860
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mechanical expiratory valve, single-use

Similar devices in this category

Other devices filed under RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from Hamilton Medical AG

See all devices from Hamilton Medical AG →

Properties

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