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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

847-0259200603 — IVDR Class A IVDR by Roboscreen GmbH

MD Atlas
Roboscreen GmbH

EUDAMED last updated this device on May 20, 2026

847-0259200603

426238673025920HW

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Roboscreen GmbH
UDI-DI code: 04262386730018
Reference / catalog number: 847-0259200603

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Manufacturer information

Organization name: Roboscreen GmbH
SRN: DE-MF-000024661
Manufacturer status: Active

Critical warnings

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

CW265
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Sep 29, 2020	Dec 31, 2029

Device identification

Trade name: not provided
UDI-DI code: 04262386730018
Basic UDI-DI: 426238673025920HW
Reference / catalog number: 847-0259200603
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 INSTANT Virus RNA/DNA Kit is intended for isolation of viral RNA and DNA from 400 µl of cell-free human body fluids. The isolation procedure is based on the spin-column based solid phase extraction technology and is optimized for preparation of highly pure viral RNA and DNA from human plasma and serum, cerebrospinal fluid and swab- and stool-supernatants. INSTANT Virus RNA/DNA Kit is designed to be used in combination with qualitative and quantitative Real-Time PCR methods for diagnostic purpose. The kit is intended for use by laboratory professionals.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

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

Related devices

847-0259200602426238673025920HWOn the market

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.