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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

800062-1CS — IVDD — Annex II List A IVDD by PRIMA Lab SA

MD Atlas
PRIMA Lab SA

EUDAMED last updated this device on Apr 24, 2026

800062-1CS

B-800062-1CS4B

On the marketIVDD — Annex II List A

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: PRIMA Lab SA
UDI-DI code: D-800062-1CS4B
Reference / catalog number: 800062-1CS

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Manufacturer information

Organization name: PRIMA Lab SA
SRN: CH-MF-000034473
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW999
Varování: Test uchovávejte mimo dosah dětí.
CW999
Neodporúca sa osobám, ktoré užívajú lieky proti zrážanlivosti krvi (lieky na riedenie krvi), ani osobám trpiacim hemofíliou.
CW999
Pokud test provádíte na jiné osoby, zacházejte se vzorky krve jako s potenciálne infekcními a pri provádení testu používejte jednorázové ochranné rukavice.

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Nov 27, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: D-800062-1CS4B
Basic UDI-DI: B-800062-1CS4B
Reference / catalog number: 800062-1CS
Issuing entity: EUDAMED

Classification

Risk category: IVDD — Annex II List A
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Rýchly samodiagnostický test na kvalitatívnu detekciu protilátok* proti vírusu ľudskej imunodeficiencie 1 a 2 (HIV1/HIV2) v plnej krvi * Protilátky sa môžu vytvoriť od 23 až 90 dní (tzv. časové okno) od expozície, než sa zistí infekcia HIV.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105090302HIV 1 / 2 - RT & POC

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

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.