Identity
- Trade Name
- Papir za spirometriju SP -Gem PreM 57mmx50mm EUDAMED
- Device Name
- Laboratory paper EUDAMED
- Model / Reference
- 5055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08606016909867 EUDAMED
- Basic UDI-DI
- 86050658-LAB-PAPER-EG EUDAMED
- EMDN Code
- Z1302 DIAGNOSTIC REGISTRATION PAPERS 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
Papir za spirometriju SP -Gem PreM 57mmx50mm 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-LAB-PAPER-EG | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Doo Velebit Novi Sad
- EUDAMED SRN
- RS-MF-000041733
- Authorised Representative
- Salus Cons Kft. HU-AR-000006177
Sources (1)
- EUDAMED f037997d-7adc-42fc-a0c6-69b1c9f2debe 61 fields · synced Jul 11, 2026