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Non-invasive cerebral oximetry system
EUDAMEDClass IIb (EU MDR)
Ref BRS-100BModel BRS-1、BRS-100、BRS-100A、BRS-100B、BRS-100C、BRS-1A、BRS-1B、BRS-1C
Identity
- Trade Name
- Non-invasive cerebral oximetry system EUDAMED
- Device Name
- Non-invasive Cerebral Oximetry System EUDAMED
- Model / Reference
- BRS-1、BRS-100、BRS-100A、BRS-100B、BRS-100C、BRS-1A、BRS-1B、BRS-1C EUDAMEDBRS-100B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975990940046 EUDAMED
- Basic UDI-DI
- 697599094101S9 EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Non-invasive cerebral oximetry system by Braincare (Beijing) medical device 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 | 697599094101S9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Braincare (Beijing) medical device co. LTD
- EUDAMED SRN
- CN-MF-000026170
- Authorised Representative
- NEO HEALTHIES LIMITED IE-AR-000000905
Sources (1)
- EUDAMED 282234b0-4206-44a0-beeb-a25550d78368 61 fields · synced Jun 18, 2026