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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

SmartTester — IVDR Class A IVDR by 77 Elektronika…

MD Atlas
77 Elektronika Műszeripari Kft

EUDAMED last updated this device on Feb 14, 2023

SmartTester

59973457SAUASRTGB

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: 77 Elektronika Műszeripari Kft
UDI-DI code: 05997345781372
Reference / catalog number: STR-9904

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Manufacturer information

Organization name: 77 Elektronika Műszeripari Kft
SRN: HU-MF-000004266
Manufacturer status: Active

Market distribution

Primary placement in Hungary; available across 1 country total.

Placed on the market in Hungary; per-country availability dates not published.

Device identification

Trade name: SmartTester
UDI-DI code: 05997345781372
Basic UDI-DI: 59973457SAUASRTGB
Reference / catalog number: STR-9904
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201069099VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
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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.