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EUDAMED last updated this device on Feb 13, 2026
42502032PRI0264SPRIMEDI-PHON PLUS® (transparent, O2-Anschluss) Sprechventil für Tracheotomierte, is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Primed Halberstadt Medizintechnik GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
042502032142302003551 packaging level registered — each level carries its own UDI-DI.
04250203214230× 1 unitBase unit04250203233057× 30 unitsDE-MF-000004967(01)04250203214230
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
R90060202PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USEPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.42502032PRI0264SOn the marketPRIMEDI-PHON PLUS® (blau-transparent) mit O2 Anschluss Sprechventil für Anschluß an 15 mm und 22mm Systeme42502032PRI0264SOn the marketPRIMEDI-PHON PLUS® (blau-transparent) Sprechventil für Tracheotomierte,42502032PRI0254QOn the marketPRIMEDI-PHON PLUS® (transparent) Sprechventil für Tracheotomierte,42502032PRI0254QOn the marketPRIMEDI-PHON Sprechventil für Tracheotomierte,42502032PRI0254QOn the marketPRIMEDI-PHON VENT® (PPV) Sprechventil für beatmete, tracheotomierte Patienten42502032PRI0264SOn the marketNo certificate specifically references this device's Basic UDI-DI.