# RNA CC527 Multi-Level

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/rna-cc-527>
- Manufacturer: [Rna Medical Division](https://devicerts.com/manufacturers/rna-medical-division) (FDA registration: United States)
- Device class: IVD General (EU IVDD)
- EMDN: W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC)
- GMDN: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control (52860)

## Registrations and authorizations

- **EUDAMED** · CE/IVDD · European Union · Basic UDI-DI B-10851290002444 · UDI-DI 10851290002444 · registered 2026-05-27 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 10851290002444 · listed 2019-06-03 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control [EUDAMED]; RNA [FDA GUDID (AccessGUDID)]
- Generic name: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control [FDA GUDID (AccessGUDID)]
- Device name: RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Multi [EUDAMED]
- Model / Ref / Catalog: CC527 [EUDAMED]; CC527 Multi-Level [FDA GUDID (AccessGUDID)]; CC 527 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 10851290002444 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-10851290002444 [EUDAMED]
- EMDN code: W0101050101 [EUDAMED]
- GMDN term: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control (52860) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IVD General [EUDAMED]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: France [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Single use: Yes [FDA GUDID (AccessGUDID)]
- Contains animal tissues or cells: Yes [EUDAMED]
- IVD kit: Yes [EUDAMED]
- Near-patient testing: Yes [EUDAMED]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Contains human tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- Reagent: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Professional testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: RNA CC527 Multi-Level, Rna Medical Division. deviCERTS medical device catalogue. https://devicerts.com/devices/rna-cc-527 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/rna-cc-527.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/rna-cc-527
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.