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iSmart
EUDAMEDClass IIa (EU MDR)
Ref nice 8050Model nice 8050, nice 8010Ref nice 8010
Identity
- Trade Name
- iSmart EUDAMED
- Device Name
- Heated (Respiratory) Humidifier EUDAMED
- Model / Reference
- nice 8050, nice 8010 EUDAMEDnice 8050 EUDAMEDnice 8010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989204 EUDAMED08908003989211 EUDAMED
- Basic UDI-DI
- 8908003989nice8050M4 EUDAMED
- EMDN Code
- R060201 ACTIVE VENTILATION HUMIDIFICATION SYSTEMS, EUDAMEDR060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iSmart by nice Neotech Medical Systems Pvt. Ltd., — Class IIa — 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 | 8908003989nice8050M4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- nice Neotech Medical Systems Pvt. Ltd.,
- EUDAMED SRN
- IN-MF-000010243
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (2)
- EUDAMED ec1ec29f-95b7-4fb2-b32a-0cc1ae8be4ee 61 fields · synced Jul 20, 2026
- EUDAMED 3d04ac6c-98c2-4334-b92b-a7b8f8653d68 61 fields · synced May 18, 2026