← Back to catalogue
Wireless brain blood oxygen monitoring headband
EUDAMEDClass IIb (EU MDR)
Ref /Model BRS-2
Identity
- Trade Name
- Wireless brain blood oxygen monitoring headband EUDAMED
- Device Name
- Wireless brain blood oxygen monitoring headband EUDAMED
- Model / Reference
- BRS-2 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975990940060 EUDAMED
- Basic UDI-DI
- 697599094103SD EUDAMED
- Direct Marketing DI
- 06975990940060 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
Wireless brain blood oxygen monitoring headband by Braincare (Beijing) medical device co. LTD — Class IIb — MDR — listed in EUDAMED
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 | 697599094103SD | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Braincare (Beijing) medical device co. LTD
- EUDAMED SRN
- CN-MF-000026170
- Authorised Representative
- NEO HEALTHIES LIMITED IE-AR-000000905
Sources (1)
- EUDAMED 0000fdad-6e5c-46d4-9838-12f68f8695c1 61 fields · synced Oct 6, 2026