- Role
- Country
- Date of registration
- Address
PL-MF-000023609No 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.Pathosolutions PREMIUM - Embedding cassette with triangular holes, one-piece with integral lid, BLUE is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Grzegorz Pałkowski Elektro Med. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Oct 10, 2024
590518640EM-C1700100Z8Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05905186401908
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 Poland; available across 1 country total.
Placed on the market in Poland; 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.
05905186401908Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
590518640EM-C1700100Z8EM-C1700100BUDI 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.
W05030580DEVICES FOR PATOLOGY TESTS - ACCESSORIES590518640EM-C1700204ZMOn the marketPathosolutions PREMIUM - Embedding cassette with triangular holes, in taped stacks, WHITE590518640EM-C1700204ZMOn the marketPathosolutions PREMIUM - Embedding cassette with triangular holes, in taped stacks, YELLOW590518640EM-C1700204ZMOn the marketPathosolutions PREMIUM - Embedding cassette with triangular holes, one-piece with integral lid, GRAY590518640EM-C1700100Z8On the marketPathosolutions PREMIUM - Embedding cassette with triangular holes, one-piece with integral lid, GREEN590518640EM-C1700100Z8On the marketPathosolutions PREMIUM - Embedding cassette with triangular holes, one-piece with integral lid, in taped stacks, BLUE590518640EM-C1700400ZPOn the marketNo certificate specifically references this device's Basic UDI-DI.