Identity
- Trade Name
- Usnik za spirometriju SP-U3 20mmx65mm EUDAMED
- Device Name
- Mouthpieces for spirometry EUDAMED
- Model / Reference
- 241 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08606013874823 EUDAMED
- Basic UDI-DI
- 86050658-SPYRO-NM EUDAMED
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function testing filter/mouthpiece
Usnik za spirometriju SP-U3 20mmx65mm by Doo Velebit Novi Sad — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulmonary function testing filter/mouthpiece.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 86050658-SPYRO-NM | Class I | Active |
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Manufacturer
- Manufacturer
- Doo Velebit Novi Sad
- EUDAMED SRN
- RS-MF-000041733
- Authorised Representative
- Salus Cons Kft. HU-AR-000006177
Sources (1)
- EUDAMED f9f44343-b1ba-4b96-bb2a-00338f04a94d 61 fields · synced Sep 18, 2026