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EUDAMED last updated this device on Jun 2, 2026
69528048ADT200JUDOA Cup Reader is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Assure Tech. (Hangzhou) Co., Ltd.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06952804827175ADT200，ADT201(01)06952804827175
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201069099VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER1 warning recorded — scroll inside the panel to see all entries.
CN-MF-000002170The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
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 →No certificate specifically references this device's Basic UDI-DI.
69528048A4287002HOn the marketDengue Rapid TestB-06952804816490On the marketDigital Pregnancy TestsB-06952804817671On the marketE. coli O157 Rapid TestB-06952804827045On the marketE. histolytica & Giardia lamblia & Crypto Combo Rapid Test KitB-06952804827144On the marketE2 FIAB-06952804803261On the marketCertificate health across this manufacturer's portfolio.
IX 2074650-3IssuedIX 2074650-2IssuedIX 2074650-4IssuedHX 2074650-1SupplementedIX 2074650-1IssuedNotified 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.
View in glossary →Notified 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.
View in glossary →Notified 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.
View in glossary →Notified 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.
View in glossary →Notified 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.
View in glossary →