- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 15, 2026
B-06975429090083Complex control for blood gas electrolyte &biochemistry is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Chengdu Polytech Biological Technology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CN-MF-000034373(01)06975429090083
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.
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 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | 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.
06975429090083Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-06975429090083AW03396UDI 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.
W0101060607BLOOD GAS CONTROLS -ELECTRODES OR CASSETTEPrimary 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.
B-06975429090359On the marketCoagulation Assays Kit (transmission turbidity method)B-06975429090106On the marketComplex control for blood gas electrolyte &biochemistryB-06975429090076On the marketCRP Kit（Immunoturbidimetric Assay）B-06975429090328On the marketGeneral Chemistry II Kit (Microfluidic Dry Chemistry)B-06975429090120On the marketGeneral Chemistry II Kit (Microfluidic Dry Chemistry)B-06975429090199On the marketNo 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.