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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

STR-9902-1 — IVDR Class A IVDR by 77 Elektronika…

MD Atlas
77 Elektronika Műszeripari Kft

EUDAMED last updated this device on May 25, 2022

STR-9902-1

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: 05997345779812
Reference / catalog number: STR-9902-1

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Manufacturer information

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

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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: not provided
UDI-DI code: 05997345779812
Basic UDI-DI: 59973457SAUASRTGB
Reference / catalog number: STR-9902-1
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

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Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

IX 1006099-1Issued
Technical documentationNotified body: 0197Expiry: Feb 11, 2031
IX 1006099-2Issued
Technical documentationNotified body: 0197Expiry: Feb 11, 2031
HX 1006099-1Issued
Quality management systemNotified body: 0197Expiry: Feb 11, 2031