Identity
- Trade Name
- NIRO-200NX FDA UDI
- Generic Name
- Tissue saturation oximeter FDA UDI
- Model / Reference
- C10448-20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582389010062 FDA UDI
- 510(k) Number
- K143219 FDA UDI
- FDA Product Code
- MUD FDA UDIDQA FDA UDI
- GMDN Term
- Tissue saturation oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tissue saturation oximeter
Niro-200nx by Hamamatsu Photonics K.K. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hamamatsu Photonics K.K.
Sources (1)
- FDA UDI 67458c7a-452f-4a32-b2aa-314c029380cf 33 fields · synced Jun 6, 2026