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Tissue oxygen sensor
EUDAMEDClass IIb (EU MDR)
Ref /Model BRS-1-CSL、BRS-1-CR、BRS-1-CL、BRS-1RE-CR、BRS-1RE-CXL、BRS-1RE-CSL、BRS-1RE-CL、BRS-1RE-C、BRS-1RE-CM、BRS-1RE-CSR、BRS-1-C、BRS-1-CSR、BRS-1-CM、BRS-1-CXL
Identity
- Trade Name
- Tissue oxygen sensor EUDAMED
- Device Name
- Tissue oxygen sensor EUDAMED
- Model / Reference
- BRS-1-CSL、BRS-1-CR、BRS-1-CL、BRS-1RE-CR、BRS-1RE-CXL、BRS-1RE-CSL、BRS-1RE-CL、BRS-1RE-C、BRS-1RE-CM、BRS-1RE-CSR、BRS-1-C、BRS-1-CSR、BRS-1-CM、BRS-1-CXL EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975990940510 EUDAMED
- Basic UDI-DI
- 697599094105SH EUDAMED
- Direct Marketing DI
- 06975990940510 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
Tissue 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 | 697599094105SH | 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 a5342e17-4361-4eb7-aa0a-561cd7addaa1 61 fields · synced Jun 19, 2026