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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

Novo Saliva Kit — IVDR Class A IVDR by Novogenia GmbH

MD Atlas
Novogenia GmbH

EUDAMED last updated this device on Apr 22, 2024

Novo Saliva Kit

426245622VSKPEG

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Novogenia GmbH
UDI-DI code: 04262456220012
Reference / catalog number: VSKP

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Manufacturer information

Organization name: Novogenia GmbH
SRN: AT-MF-000038731
Manufacturer status: Active

Critical warnings

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

CW010
Follow the Instructions
CW009
For single use only
CW008
Biohazard Transportbeutel für diagnostische Proben der Risikogruppe 1-3

Market distribution

Primary placement in Austria; available across 1 country total.

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

Device identification

Trade name: Novo Saliva Kit
UDI-DI code: 04262456220012
Basic UDI-DI: 426245622VSKPEG
Reference / catalog number: VSKP
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: Das Kit ist für die Eigenanwendung sowie für die professionelle Anwendung durch medizinisches Personal geeignet.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W05019002SALIVA COLLECTION DEVICES

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

Related devices

NOVO Venous Blood Kit4262456220036V9On 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.