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ValveSafe

by Meditech Endoscopy Limited

Ref INOV8-001

ValveSafe (INOV8-001) is a Class I device made by Meditech Endoscopy, Ltd., registered in EUDAMED on 31 Jan 2025 (Basic UDI-DI 5060602250017PN) and listed in FDA GUDID since 24 Aug 2023 (UDI-DI 05060602250017), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5060602250017PN Basic UDI-DI 05060602250017UDI-DIDate31 Jan 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060602250017 UDI-DI Date24 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5060602250017PN registered 31 Jan 2025 Active
  • FDA GUDID UDI-DI 05060602250017 listed 24 Aug 2023 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 05060602250017
  2. Registered EUDAMED 5060602250017PN

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  • Withdrawn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

Generic name
Device sterilization/disinfection container, single-use
Model / reference
INOV8-001
Primary DI / UDI-DI
05060602250017 EUDAMED
15060602250014 GUDID
Basic UDI-DI
5060602250017PN
FDA product code
FFY
EMDN code
S010499 Sterilisation containers - other
GMDN term
Device sterilization/disinfection container, single-use
Device class
Class I
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05060602250017
GUDID
15060602250014

The registries describe this device under different primary UDI-DIs (EUDAMED lists 05060602250017; FDA GUDID lists 15060602250014), so their flags are not compared.

Manufacturer details

EUDAMED SRN
GB-MF-000014143
Authorised representative
Elara Pharmaservices Europe Ltd IE-AR-000011852

Similar devices in this category

Other devices filed under CONTAINERS FOR STERILISATION.

Other devices from Meditech Endoscopy, Ltd.

See all devices from Meditech Endoscopy, Ltd. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)