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Organization name
UDI-DI code
Reference / catalog number

VINC0008 — Class IIa MDD by VINCENTKA a.s.

MD Atlas
VINCENTKA a.s.

EUDAMED last updated this device on Mar 20, 2026

VINC0008

B-08594027250149

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: VINCENTKA a.s.
UDI-DI code: 08594027250149
Reference / catalog number: VINC0008

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Manufacturer information

Organization name: VINCENTKA a.s.
SRN: CZ-MF-000032136
Manufacturer status: Active

Related devices

VINC0008859402725VINCENTKA2NOn the market VINC0007B-08594027250132On the market VINC0007859402725VINCENTKA2NOn the market VINC0003859402725VINCENTKA2NOn the market VINC0003B-08594027250255On 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.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Feb 20, 2012	Still on market
Slovakia	Feb 20, 2013	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594027250149
Basic UDI-DI: B-08594027250149
Reference / catalog number: VINC0008
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Proplachovací roztok – zdravotnický prostředek určený k proplachování nosních dutin a nosohltanu pomocí plastové proplachovací konévky z důvodů preventivních, v akutních stavech (u pacientů se záněty horních cest dýchacích, akutních i chronických; po operacích nosní přepážky, nosní sliznice; po operacích v oblasti nosních dutiny, vedlejších nosních dutin, slzných cest i nádorů těchto oblastí; po endoskopických operacích; po operacích nosohltanu, měkkého patra; u pacientů s tvorbou krust a hustého hlenu; u pacientů s přední suchou rýmou), jako příprava před aplikací do nosu užívaných (aplikovaných) léků, protože zvyšuje jejich účinnost; před operacemi nosních a vedlejších nosních dutin a před endoskopickým vyšetřením nosních dutin a nosohltanu.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q030103NASAL IRRIGATION SOLUTIONS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
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