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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

3315-500 — IVDR Class A IVDR by IMMUNOTECH s.r.o.

MD Atlas
IMMUNOTECH s.r.o.

EUDAMED last updated this device on Dec 12, 2024

3315-500

1509959053315-500EW

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: IMMUNOTECH s.r.o.
UDI-DI code: 15099590775155
Reference / catalog number: 3315-500

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Manufacturer information

Organization name: IMMUNOTECH s.r.o.
SRN: CZ-MF-000001761
Manufacturer status: Active

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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.

Critical warnings

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

CW010
see IFU

Market distribution

Primary placement in Czechia; available across 3 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
France		Still on market
XI		Still on market

Device identification

Trade name: not provided
UDI-DI code: 15099590775155
Basic UDI-DI: 1509959053315-500EW
Reference / catalog number: 3315-500
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: The viRNAtrap DNAPlusTM Extraction KIT is an in vitro diagnostic manual medical device intended to be used by healthcare professionals for isolation of nucleic acids from whole blood, dried blood spots, serum, plasma, nasopharyngeal swabs, saliva, urine and genital swabs.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W02069085VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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