- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jul 30, 2026
693659570132MSCleaning Solution(Direct Method) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by MedicalSystem Biotechnology Co., Ltd.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06936595776867BF0132PCN-MF-000010246(01)06936595776867
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
For in vitro diagnostic use only. If it accidentally splashes onto the human body surface such as the skin or eyes, it must be rinsed with clean water. If swallowed by mistake, medical treatment at a hospital is required. When in use, protective measures should be taken and the precautions for operating laboratory reagents should be followed. All waste should be disposed of in accordance with local regulations. Avoid high temperatures and direct sunlight.
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 Türkiye; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01019001BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)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-06936595751819On the marketCholyglycine Kit (Latex-Enhanced Immunoturbidimetric Method)B-06936595750683On the marketCleaning fluid for urinalysis693659579912QTOn the marketCleanser693659579908R4On the marketCollagen Type IV Kit (CLIA)B-06936595751147On the marketComplement C1q Kit (Immunoturbidimetric Method)B-06936595750898On the market