Identity
- Trade Name
- INOwill EUDAMED
- Device Name
- Nitric Oxide Generator EUDAMEDINOwill Nitric Oxide Generator and Delivery System EUDAMEDTube Accessories EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973454710037 EUDAMED06973454710020 EUDAMED06973454710167 EUDAMED
- Basic UDI-DI
- 697345471INOWQT EUDAMED697345471N200GH EUDAMED697345471TAQ1P3 EUDAMED
- Direct Marketing DI
- 06973454710037 EUDAMED06973454710020 EUDAMED06973454710167 EUDAMED
- EMDN Code
- Z12159099 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER EUDAMEDR020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass 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
Yes
EUDAMED
Measuring Function
No
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
INOwill by Nanjing Novlead Biotechnology Co., Ltd. — Class IIb — 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 | 697345471INOWQT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nanjing Novlead Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023197
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (3)
- EUDAMED ff0306b1-b6d4-421b-8e37-532bb4078b13 61 fields · synced Jul 17, 2026
- EUDAMED e6387bdb-532a-4251-b71a-75816a953f69 61 fields · synced May 17, 2026
- EUDAMED dddc3aa8-6b00-40f2-ac44-0b67612bde54 61 fields · synced May 18, 2026