Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

612224 — IVDD — Self-testing IVDD by BIOSYNEX

MD Atlas
BIOSYNEX

EUDAMED last updated this device on May 11, 2026

612224

B-03518646122248

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BIOSYNEX
UDI-DI code: 03518646122248
Reference / catalog number: 612224

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: BIOSYNEX
SRN: FR-MF-000014073
Manufacturer status: Active

Related devices

1120001-50353267F00074P8GOn the market 860045B-05400606954236On the market AMAZON BASIC CARE VAGINAL INFECTIONS TESTB-05400606954229On the market 1090003B-03700531705135On the market 1090003_CB-03532670103684On the market

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03518646122248
Basic UDI-DI: B-03518646122248
Reference / catalog number: 612224
Issuing entity: GS1

Classification

Risk category: IVDD — Self-testing
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: HCG Pregnancy Rapid Test ElleTest is a rapid, one-step lateral flow immunoassay in midstream format for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy.
Additional information URL: https://www.biosynex.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102050206B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

030/MDRIssued
Quality management systemNotified body: 0051Expiry: Jun 5, 2027
G10 002187 0009Issued
Quality management systemNotified body: 0123Expiry: Sep 25, 2028