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Saline solution 4ml

by VIAMAR INTERNATIONAL, s.r.o.

Ref 98326-200

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Overview

Saline solution 4ml is a widely used medical device designed for the administration of sterile solutions to patients. This device is sterilized according to standard criteria and is available for purchase in various quantities, making it suitable for a range of medical applications. With its accurate measurement function and compatible reagents, saline solution 4ml is a reliable option for healthcare professionals.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number85941999298089CK Basic UDI-DI 08594199922073UDI-DIDate9 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Fyziologický roztok
Model / Reference
98326-200
Primary DI / UDI-DI
08594199922073
Basic UDI-DI
85941999298089CK
EMDN Code
W0104010206 Media in tubes (solid & liquid)
Device Class
Class A
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000038013

Other devices from VIAMAR INTERNATIONAL, s.r.o.

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No