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EUDAMED last updated this device on May 19, 2026
86050658-SPYRO-NMUsnik za spirometriju SP-U1 16mmx65mm is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by DOO VELEBIT NOVI SAD. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08606013873222161(01)08606013873222
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12150185SPIROMETRY INSTRUMENTS - CONSUMABLESRS-MF-000041733No certificate specifically references this device's Basic UDI-DI.
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.The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Romania; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | — | Still on market |
| Croatia | — | Still on market |
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
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 →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 →86050658-ULTRASOUND-THOn the marketPapir za ultrazvuk SM 105mmx20m86050658-ULTRASOUND-THOn the marketPapir za ultrazvuk TS 210mmx15m86050658-ULTRASOUND-THOn the marketUsnik za spirometriju SP-U10 18mmx70mm86050658-SPYRO-NMOn the marketUsnik za spirometriju SP-U11 20mmx70mm86050658-SPYRO-NMOn the marketUsnik za spirometriju SP-U12 22mmx70mm86050658-SPYRO-NMOn the market