Identity
- Trade Name
- SnapshotNIR EUDAMEDFDA UDI
- Generic Name
- Tissue saturation oximeter FDA UDI
- Device Name
- SnapshotNIR EUDAMEDTissue oxygenation imaging device FDA UDI
- Model / Reference
- KD205 EUDAMEDFDA UDI
- Description
- Tissue oxygenation imaging device FDA UDI
Identifiers
- Primary DI / UDI-DI
- B376KD2050 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B376KD205TQ EUDAMED
- FDA Product Code
- MUD FDA UDI
- EMDN Code
- Z12040199 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Tissue saturation oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
SnapshotNIR by Kent Imaging Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201976 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B376KD205TQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kent Imaging Inc.
- EUDAMED SRN
- CA-MF-000042637
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 59c6d55d-6e6f-46d7-863f-06f49efe132d 61 fields · synced Jul 9, 2026
- FDA UDI c6f8f05e-e34d-4851-8f3e-61dca07561ec 33 fields · synced May 29, 2026
- FDA 510(k) K201976 1 fields · synced May 18, 2026