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

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Organization name
UDI-DI code
Reference / catalog number

ACO-01-001M — IVDD — Self-testing IVDD by BIOSYNEX

MD Atlas
BIOSYNEX

EUDAMED last updated this device on May 13, 2026

ACO-01-001M

B-05206977000035

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BIOSYNEX
UDI-DI code: 05206977000035
Reference / catalog number: ACO-01-001M

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Manufacturer information

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

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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 EL; available across 1 country total.

Country	On market since	Until
ELPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05206977000035
Basic UDI-DI: B-05206977000035
Reference / catalog number: ACO-01-001M
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: Test for self-diagnosis that detects human chrionic 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