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Blue Diode Laser Surgical System
EUDAMEDClass IIb (EU MDR)
Ref /Model BR6800 and BR6900
Identity
- Device Name
- Blue Diode Laser Surgical System EUDAMED
- Model / Reference
- BR6800 and BR6900 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972141900188 EUDAMED06972141900027 EUDAMED
- Basic UDI-DI
- 69721419020015K EUDAMED
- Direct Marketing DI
- 06972141900188 EUDAMED06972141900027 EUDAMED
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Blue Diode Laser Surgical System by Blueray Medical Technologies, 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 | 69721419020015K | Class IIb | Active |
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Manufacturer
- Manufacturer
- Blueray Medical Technologies, Ltd.
- EUDAMED SRN
- CN-MF-000044328
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED ce35114a-37a1-4c9c-9322-c1be9fc1e701 61 fields · synced Jul 14, 2026
- EUDAMED c2c351a0-5763-4394-9332-6be58a3b8ab6 61 fields · synced May 19, 2026