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JP-MF-000013944Autokit CH50 Set is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by FUJIFILM Wako Pure Chemical Corporation. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 3, 2026
49874814987481164833V4Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04987481164840
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
7 warnings recorded — scroll inside the panel to see all entries.
CW010CW267CW032CW129CW132CW018CW029Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
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.
Primary placement in Germany; available across 14 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Czechia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Ireland | — | Still on market |
| Italy | — | Still on market |
| Netherlands | — | Still on market |
| Portugal | — | Still on market |
| Sweden | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04987481164840Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
49874814987481164833V4999-40701UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102010208TOTAL COMPLEMENT ACTIVITY (CH50)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.49874811498748116385727On the marketAutokit 3-HB R1 Set49874814987481164789VSOn the marketAutokit 3-HB R2 Set49874814987481164789VSOn the marketAutokit CH50 Set49874814987481164833V4On the marketAutokit Total Ketone Bodies R1 Set49874814987481164802UROn the marketAutokit Total Ketone Bodies R2 Set49874814987481164802UROn the marketNo certificate specifically references this device's Basic UDI-DI.