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Tissue oxygen probe
EUDAMEDClass IIb (EU MDR)
Ref 6975990940077、6975990940084、6975990940138Model BRS-1-C、BRS-1-R、BRS-1-RR、BRS-1-RL、BRS-1-RXL、BRS-1-RM、BRS-1-RSR、BRS-1-RSL、BRS-1RE-R、BRS-1RE-RR、BRS-1RE-RL、BRS-1RE-RXL、BRS-1RE-RM、BRS-1RE-RSR、BRS-1RE-RSL
Identity
- Device Name
- Tissue oxygen probe EUDAMED
- Model / Reference
- BRS-1-C、BRS-1-R、BRS-1-RR、BRS-1-RL、BRS-1-RXL、BRS-1-RM、BRS-1-RSR、BRS-1-RSL、BRS-1RE-R、BRS-1RE-RR、BRS-1RE-RL、BRS-1RE-RXL、BRS-1RE-RM、BRS-1RE-RSR、BRS-1RE-RSL EUDAMED6975990940077、6975990940084、6975990940138 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975990940077 EUDAMED
- Basic UDI-DI
- 697599094102SB EUDAMED
- EMDN Code
- V0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES 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
Tissue oxygen probe 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 | 697599094102SB | 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 36f424a9-3617-4bb4-8f23-d54017042bfa 61 fields · synced Jun 18, 2026