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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

19509 — Class I MDR by Theodor Labarre…

MD Atlas
Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH

EUDAMED last updated this device on Jun 25, 2022

19509

426074129Ventil6K

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH
UDI-DI code: 04260741290153
Reference / catalog number: 19509

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Manufacturer information

Organization name: Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH
SRN: DE-MF-000011889
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 04260741290153
Basic UDI-DI: 426074129Ventil6K
Reference / catalog number: 19509
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Das Sprechventil für Tracheostomakanülen ist für Patienten mit erhaltener Stimmfunktion des Kehlkopfes ein Hilfsmittel zum fingerfreien Sprechen.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R900602PHONATION VALVES FOR TRACHEOSTOMY

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

19982426074129AdapterBCOn the market 19986426074129AdapterBCOn the market 19988426074129AdapterBCOn the market 19984426074129AdapterBCOn the market 1726VF426074129Ventil6KOn 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.