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Patient Interfaces
EUDAMEDClass IIa (EU MDR)
Ref Nasal cannula, Nasal prongs ,Nasal mask , Nasal T bar prongs ,Resuscitation face mask and Flow tubeModel Nasal cannula, Nasal prongs, Nasal mask, Nasal T bar prongs, Resuscitation face mask and Flow tube
Identity
- Device Name
- Patient Interfaces EUDAMED
- Model / Reference
- Nasal cannula, Nasal prongs, Nasal mask, Nasal T bar prongs, Resuscitation face mask and Flow tube EUDAMEDNasal cannula, Nasal prongs ,Nasal mask , Nasal T bar prongs ,Resuscitation face mask and Flow tube EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908003989754 EUDAMED
- Basic UDI-DI
- 08908003989PI6P EUDAMED
- EMDN Code
- R03010201,R0301020302 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Patient Interfaces 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 | 08908003989PI6P | 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 362f605f-86b9-4b81-a1b6-4b7c704fcde8 61 fields · synced Jul 16, 2026
- EUDAMED 362f605f-86b9-4b81-a1b6-4b7c704fcde8-1 61 fields · synced Jun 10, 2026