Identity
- Trade Name
- Nuvo Nano EUDAMEDFDA UDI
- Generic Name
- Stationary oxygen concentrator FDA UDI
- Device Name
- Nuvo Nano EUDAMEDNidek Medical Oxygen Concentrators EUDAMEDPORTABLE OXYGEN CONCENTRATOR FDA UDI
- Model / Reference
- 855 EUDAMEDFDA UDI
- Description
- PORTABLE OXYGEN CONCENTRATOR FDA UDI
Identifiers
- Catalog Number
- 855 FDA UDI
- Primary DI / UDI-DI
- 00038214002466 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00038214002466 EUDAMED00038214NIDEK4L EUDAMED
- Direct Marketing DI
- 00038214002466 EUDAMED
- 510(k) Number
- K192693 FDA UDI
- FDA Product Code
- CAW FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Stationary oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5440 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Nuvo Nano by Nidek Medical Products Inc. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00038214002466 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00038214002466 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Nidek Medical Products Inc.
- EUDAMED SRN
- US-MF-000007253
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (3)
- EUDAMED cb276f00-90da-4957-8055-188feb7aee02 61 fields · synced Sep 18, 2026
- EUDAMED 524f8eec-384e-49ee-9428-f85557e36466 61 fields · synced May 18, 2026
- FDA UDI e8262a6b-da70-4710-9642-026d3a5101f8 37 fields · synced May 30, 2026