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ES-MF-000000153GIEMSA STAIN 1000ML is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Deltalab, S.L.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 15, 2026
84356058UDI-DI-186HPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08435263820331
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.
Not suitable for any other application than its intended use. - Do Not use if packaging is damaged. - Do Not use the product if it has changed its original color. - Do Not use if expiration date is overcome. - Manage as hazardous waste
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 Spain; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
| Cyprus | — | Still on market |
| EL | — | Still on market |
| Lithuania | — | Still on market |
| Latvia | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | 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.
08435263820331Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
84356058UDI-DI-186H808101UDI 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.
W0103010399HAEMATOLOGY STAINS FOR MICROSCOPY - OTHER84356058UDI-DI-246COn the marketFLOCKED SWAB STANDARD 80MM FLOW84356058UDI-DI-246COn the marketFLACON SECURITÉ 40ML84356058UDI-DI-156BOn the marketGIEMSA STAIN 250ML84356058UDI-DI-186HOn the marketGLASS VSG PIPETTE 0-180mm84356058UDI-DI-166DOn the marketGREY CONT. 60ML PP W/SPOON RED CAP84356058UDI-DI-156BOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
2024 PR 0038IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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