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RNA CC527 Multi-Level

by Rna Medical Division

Ref CC527

RNA CC527 Multi-Level (CC 527) is an in vitro diagnostic device (EU IVDD general IVD; EMDN category assayed multicomponent controls (cc)) made by Rna Medical Division, registered in EUDAMED on 27 May 2026 (Basic UDI-DI B-10851290002444) and listed in FDA GUDID since 3 Jun 2019 (UDI-DI 10851290002444), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-10851290002444 Basic UDI-DI 10851290002444UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10851290002444 UDI-DI Date3 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10851290002444 registered 27 May 2026 Active
  • FDA GUDID UDI-DI 10851290002444 listed 3 Jun 2019 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 10851290002444
  2. Registered EUDAMED B-10851290002444

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control EUDAMED
RNA GUDID
Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Device name
RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Multi
Model / Ref / Catalog
CC527 EUDAMED
CC527 Multi-Level GUDID
CC 527 GUDID
Primary DI / UDI-DI
10851290002444
Basic UDI-DI
B-10851290002444
EMDN code
W0101050101 Assayed multicomponent controls (cc)
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Device class
Class IVD General
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
Model / referenceEUDAMED
CC527
GUDID
CC527 Multi-Level

Related devices

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Similar devices in this category

Other devices filed under ASSAYED MULTICOMPONENT CONTROLS (CC).

Other devices from Rna Medical Division

See all devices from Rna Medical Division →

Properties

  • Single use
  • Contains animal tissues or cells
  • IVD kit
  • Near-patient testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)