- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Feb 18, 2024
6974195307321052SKY012877SKYE203-8 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by MABSKY BIO-TECH CO., LTD.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974195301621 SKYE203-8(01)06974195301621
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01019099CLINICAL CHEMISTRY REAGENTS - OTHERPrimary placement in Netherlands; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Mar 1, 2024 | Jan 1, 2026 |
| Türkiye | Mar 1, 2024 | Jan 1, 2026 |
CN-MF-000038680The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.