Identity
- Trade Name
- Usnik za spirometriju SP-U17 16mmx90mm EUDAMED
- Device Name
- Mouthpieces for spirometry EUDAMED
- Model / Reference
- 9351 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08606017760238 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
Usnik za spirometriju SP-U17 16mmx90mm by Doo Velebit Novi Sad — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 a34e5965-d72d-4b3e-8039-906da7453f2e 61 fields · synced Jul 18, 2026