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Ventilator
EUDAMEDClass IIb (EU MDR)
Ref NV60Model NV50, NV50A, NV50B, NV60, NV60A, NV60B, NV70, NV70A, NV70B
Identity
- Trade Name
- Ventilator EUDAMED
- Device Name
- Ventilator EUDAMED
- Model / Reference
- NV50, NV50A, NV50B, NV60, NV60A, NV60B, NV70, NV70A, NV70B EUDAMEDNV60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429024968 EUDAMED
- Basic UDI-DI
- 69454290GV003NA EUDAMED
- Direct Marketing DI
- 06945429024968 EUDAMED
- EMDN Code
- Z1203010504,Z1203020299 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Iceland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Ventilator by Shenzhen Comen Medical Instruments 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 | 69454290GV003NA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 07dd9935-a012-43d4-ae83-5b8048aa5ab3 61 fields · synced Jun 19, 2026