Organization name

Cupid Limited

SRN

IN-MF-000033199

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use

  Read the Instructions for Use before carrying out the test and instructions must be followed exactly to get accurate results.

• Do not re-use

  Do not re-use the test device.

• Do not use if package is damaged

  Do not use device if packaging is damaged

• Contains biological material of animal origin

  Goat anti-mouse IgG, hCG Alpha, hCG Beta and Bovine Serum Albumin are used in Pregnancy hCG Test Kit which are animal origin raw material.

Primary placement in Austria; available across 32 countries total.

Trade name

CupiSURE

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08906005288042

Basic UDI-DI

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.

890600528cuphcgKG

Reference / catalog number

CUPHCG-01

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

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.

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The Pregnancy hCG Test Kit is a single use device for preliminary qualitative detection of human chorionic gonadotropin (hCG) within 5 minutes. The kit includes a test cassette and a dropper for performing the test, which are packed in primary aluminium foil pouch along with a dessicant.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102160302HCG - RT & POC

• IVDR Class B medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.