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- Date of registration
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EUDAMED last updated this device on Dec 30, 2025
69528048A030100WFHuman Chorionic Gonadotropin Combo Rapid Test (20/20mIU) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Assure Tech. (Hangzhou) Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CN-MF-000002170(01)06952804833459
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.
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 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | 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.
06952804833459Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
69528048A030100WFFormat(Strip):A02600;Format(Device):A03010UDI 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.
W0102050205TOTAL HUMAN CHORIONIC GONADOTROPINPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →69528048AB03F0087On the marketHAV IgM Rapid Test69528048A403100XPOn the marketHemoglobin Test Meter69528048AS-XH-02UYOn the marketInfluenza A/B Rapid Test Device69528048A46071028On the marketInfluenza A/B&ADV Antigen combo Test69528048A4D33006MOn the marketLactate Test Meter69528048LAC-101FFOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HX 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 →