- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Mar 31, 2026
B-GCRSV-PN10HG2MRSV Antigen Control Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Healgen Scientific Limited Liability Company. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-GCRSV-PN10HG2MGCRSV-PN10D-GCRSV-PN10HG2M
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105080804OTHER VIROLOGY CONTROLS - INF.IMM.3 warnings recorded — scroll inside the panel to see all entries.
US-MF-000018839Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.B-GCROA-602aHG5ZOn the marketRotavirus Rapid Test Cassette (Feces)B-GCROA-602CaHGBBOn the marketRSV Antigen Control KitB-GCRSV-PN2HGUBOn the marketRSV Antigen FIA Control KitB-FCRSV-PN2HGTCOn the marketRSV Antigen Fluorescence Rapid Test Cassette (Swab)B-FCRSV-502CaHGU8On the marketRSV Antigen Fluorescent Rapid Test Cassette (Swab)B-FCRSV-502aHGKSOn the market