- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jan 15, 2025
8684341089BPSF00001FMBPSF00001 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Medikal Olusum Sanayi ve Ticaret Limited Sirketi. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08684341089164BPSF00001 (01)08684341089164
European Medical Device Nomenclature — the EU product classification assigned to this device.
U09030301UROGENITAL CYTOLOGY BRUSHESPrimary placement in Türkiye; available across 1 country total.
Placed on the market in Türkiye; per-country availability dates not published.
TR-MF-000026274The 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 →86813490805BKKS00001J8On the marketXylene Histological Grade 5L86813490805BKKS00002JAOn the marketZiehl Neelsen 100 Test869893434BKZN00001TUOn the marketBPKT000018684341089BPKT00001H3On the marketBPVI000098684341089BPVI00009JXOn the marketBMLS000038684341089BMLS00003FJOn the marketNo 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.