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Sleep Apnoea Breathing Therapy Systems
EUDAMEDClass IIa (EU MDR)
Ref BPAP20SRef APAP20ERef BPAP20AutoRef BPAP20AutoERef BPAP20PlusRef BPAP25MPlusRef BPAP30VFRef BPAP25ERef BPAP25AutoSRef APAP20Ref BPAP25ProRef CPAP20Ref BPAP20AutoSRef BPAP30PlusRef BPAP30ProRef CPAP20E
Identity
- Trade Name
- Sleep Apnoea Breathing Therapy Systems EUDAMED
- Device Name
- Sleep Apnoea Breathing Therapy Systems EUDAMED
- Model / Reference
- BPAP20S EUDAMEDAPAP20E EUDAMEDBPAP20Auto EUDAMEDBPAP20AutoE EUDAMEDBPAP20Plus EUDAMEDBPAP25MPlus EUDAMEDBPAP30VF EUDAMEDBPAP25E EUDAMEDBPAP25AutoS EUDAMEDAPAP20 EUDAMEDBPAP25Pro EUDAMEDCPAP20 EUDAMEDBPAP20AutoS EUDAMEDBPAP30Plus EUDAMEDBPAP30Pro EUDAMEDCPAP20E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957469402033 EUDAMED06957469403764 EUDAMED06957469402088 EUDAMED06957469403795 EUDAMED06957469402040 EUDAMED06957469402064 EUDAMED06957469403863 EUDAMED06957469403832 EUDAMED06957469403788 EUDAMED06957469402019 EUDAMED06957469402101 EUDAMED06957469402026 EUDAMED06957469403771 EUDAMED06957469402118 EUDAMED06957469402125 EUDAMED06957469403757 EUDAMED
- Basic UDI-DI
- 6957469402009E8 EUDAMED
- Direct Marketing DI
- 06957469401135 EUDAMED06957469402026 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
Sleep Apnoea Breathing Therapy Systems by Shenyang RMS Medical Tech 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 | 6957469402009E8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenyang RMS Medical Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000023286
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (16)
- EUDAMED 8b57b206-494e-48a2-aa82-118f9b3e5543 61 fields · synced Oct 5, 2026
- EUDAMED cb2450e7-4331-4869-956c-c5e0f02740da 61 fields · synced May 16, 2026
- EUDAMED 1d3b6102-7cc1-4a07-9176-5bdec97517ee 61 fields · synced May 16, 2026
- EUDAMED 7d140829-26bf-40b1-a313-5f4c00cbb97f 61 fields · synced May 16, 2026
- EUDAMED dd6acb04-3c95-4484-8602-daaef481b237 61 fields · synced May 17, 2026
- EUDAMED 02846ff1-c9b4-4316-a8ac-ebec10d4b2bb 61 fields · synced May 17, 2026
- EUDAMED 9a49c07a-5705-40c2-b77c-c97a1f157bf2 61 fields · synced May 17, 2026
- EUDAMED d51f9ac0-1622-4fd4-8f58-d845bbf10c21 61 fields · synced May 17, 2026
- EUDAMED 720b045c-65af-4966-a0b9-2806361faf46 61 fields · synced May 17, 2026
- EUDAMED c7be751d-6d2c-469f-8db3-32aa311904b2 61 fields · synced May 17, 2026
- EUDAMED e6524b94-f859-421d-a693-9d3fae96c9d0 61 fields · synced May 18, 2026
- EUDAMED f7ffa7a9-edba-4ca5-9470-3b3cb2b2df23 61 fields · synced May 18, 2026
- EUDAMED 766c091b-4d74-4d5b-b776-ab8013e4ca17 61 fields · synced May 18, 2026
- EUDAMED cca68c81-e17f-4497-a441-35880564cf9f 61 fields · synced May 18, 2026
- EUDAMED b0ffad1e-6459-4c30-9c96-1a1eb0abba95 61 fields · synced May 18, 2026
- EUDAMED 4ccc7526-d418-4df3-8eba-ca07118cfa7b 61 fields · synced May 18, 2026