Identity
- Trade Name
- bi-rich EUDAMED
- Device Name
- Sleep apnoea breathing therapy equipment EUDAMED
- Model / Reference
- BR-25ST EUDAMEDBR-20A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070910204 EUDAMED
- Basic UDI-DI
- 697507091ST3M EUDAMED
- Direct Marketing DI
- 06975070910204 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
bi-rich by ShenZhen Bi-rich Medical Devices Co., Ltd — Class IIa — 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 | 697507091ST3M | Class IIa | Active |
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Manufacturer
- Manufacturer
- ShenZhen Bi-rich Medical Devices Co., Ltd
- EUDAMED SRN
- CN-MF-000023061
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 69a29ceb-46f4-4e44-aaa1-2adc974a26b1 61 fields · synced Oct 6, 2026