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VO200 NeurOs Cerebral Oximetry System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref OS-NeurOs, SEN-NeurOs Model Mespere VO 200 510(k) K182242
Identity
- Trade Name
- Mespere FDA UDI
- Generic Name
- Cerebral oximeter FDA UDI
- Device Name
- VO200 NeurOs Cerebral Oximetry System EUDAMED
- Model / Reference
- Mespere VO 200 EUDAMEDOS-NeurOs, SEN-NeurOs EUDAMEDSEN-NeurOs FDA UDI
Identifiers
- Primary DI / UDI-DI
- M9831501000021 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M9831501000021 EUDAMED
- 510(k) Number
- K182242 FDA UDI
- FDA Product Code
- MUD FDA UDI
- EMDN Code
- V0380,V92 EUDAMED
- GMDN Term
- Cerebral oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Türkiye 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
VO200 NeurOs Cerebral Oximetry System by Mespere LifeSciences Inc — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Manufacturer's product page: NeurOs Cerebral Oximetry
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182242 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-M9831501000021 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mespere LifeSciences Inc
- EUDAMED SRN
- CA-MF-000018414
- FDA Applicant
- Mespere Lifesciences, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 193d3557-93e2-4c15-b43b-ea6db1a3f8f4 85 fields · synced Jun 19, 2026
- FDA UDI fab3b9ae-d97c-4f0a-85e2-f6a06348b348 33 fields · synced May 29, 2026
- EUDAMED 193d3557-93e2-4c15-b43b-ea6db1a3f8f4-1 61 fields · synced Jun 10, 2026
- FDA 510(k) K182242 1 fields · synced May 18, 2026