- Role
- Country
- Date of registration
- Address
GB-MF-000022744No 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.CELLSAFE+ BIOPSY CAPSULE - WHITE is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by CellPath Ltd. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 10, 2023
05056256EBE001X9Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05056256123883
The 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.
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 Netherlands; available across 1 country total.
Placed on the market in Netherlands; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05056256123883Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
05056256EBE001X9EBE-0201-03AUDI 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.
W0202050385LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLESNo certificate specifically references this device's Basic UDI-DI.
05056256EBE001X9On the marketCELLSAFE+ BIOPSY CAPSULE - BLUE05056256EBE001X9On the marketCELLSAFE+ BIOPSY CAPSULE - WHITE05056256EBE001X9On the marketCELLSOFT - 4 x 125ml05056256EAA001W2On the marketCELLSOFT - 4 x 125ml05056256EAA001W2On the marketCELLSTOR - 10L - 10% NEUTRAL BUFFERED FORMALIN05056256BAF002VYOn the market