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Cerebral blood oxygen sensor
EUDAMEDClass IIb (EU MDR)
Ref /Model BRS-1MR-B、BRS-1-RM、BRS-1MR-C、BRS-1RE-R、BRS-1-RSR、BRS-1RE-RSL、BRS-1-RR、BRS-1RE-RL、BRS-1-RL、BRS-1RE-RXL、BRS-1-RXL、BRS-1RE-RM、BRS-1RE-RSR、BRS-1MR-A、BRS-1-RSL、BRS-1RE-RR、BRS-1-R
Identity
- Trade Name
- Cerebral blood oxygen sensor EUDAMED
- Device Name
- Cerebral blood oxygen sensor EUDAMED
- Model / Reference
- BRS-1MR-B、BRS-1-RM、BRS-1MR-C、BRS-1RE-R、BRS-1-RSR、BRS-1RE-RSL、BRS-1-RR、BRS-1RE-RL、BRS-1-RL、BRS-1RE-RXL、BRS-1-RXL、BRS-1RE-RM、BRS-1RE-RSR、BRS-1MR-A、BRS-1-RSL、BRS-1RE-RR、BRS-1-R EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975990940206 EUDAMED
- Basic UDI-DI
- 697599094104SF EUDAMED
- Direct Marketing DI
- 06975990940206 EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cerebral blood oxygen sensor 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 | 697599094104SF | 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 deeb50ca-860c-4e9e-9442-921d5c8a543d 61 fields · synced Jun 20, 2026