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Medical Ventilator
EUDAMEDClass IIa (EU MDR)
Ref BPAP HPModel BPAP-HD80Ref BPAP HORef BPAP HF90Ref BPAP HA80Ref BPAP HRef BPAP HE90Ref BPAP HFRef BPAP HD80Ref BPAP H30Ref BPAP H20
Identity
- Device Name
- Medical Ventilator EUDAMED
- Model / Reference
- BPAP-HD80 EUDAMEDBPAP HP EUDAMEDBPAP HO EUDAMEDBPAP HF90 EUDAMEDBPAP HA80 EUDAMEDBPAP H EUDAMEDBPAP HE90 EUDAMEDBPAP HF EUDAMEDBPAP HD80 EUDAMEDBPAP H30 EUDAMEDBPAP H20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957469401715 EUDAMED06957469401685 EUDAMED06957469401753 EUDAMED06957469401777 EUDAMED06957469401692 EUDAMED06957469401760 EUDAMED06957469401678 EUDAMED06957469401807 EUDAMED06957469401722 EUDAMED06957469401746 EUDAMED
- Basic UDI-DI
- 6957469402005DY EUDAMED
- EMDN Code
- R0499 RESPIRATORY FILTERS - OTHER 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
Medical Ventilator 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 | 6957469402005DY | 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 (10)
- EUDAMED 88bd45de-aa39-4bf8-a816-3d871b9a0363 61 fields · synced Oct 6, 2026
- EUDAMED 34351d8d-30c8-494a-8e3d-30d78663fbb5 61 fields · synced May 16, 2026
- EUDAMED 6fd7b644-7bd3-4f70-9683-fb837b667c43 61 fields · synced May 16, 2026
- EUDAMED 6c15b800-03db-4774-a42b-dd359714ef9d 61 fields · synced May 17, 2026
- EUDAMED 0f8a40ee-ac9f-4975-a322-a61049fb370d 61 fields · synced May 18, 2026
- EUDAMED 4a8e397a-3b9e-4883-aeef-ea94b396fb73 61 fields · synced May 18, 2026
- EUDAMED 71740f4b-011e-47a4-b2db-58fa29227717 61 fields · synced May 18, 2026
- EUDAMED dd639a3c-9fe7-47e8-a378-cb1b43f5d3d9 61 fields · synced May 18, 2026
- EUDAMED 08f22222-ce42-473a-b337-a17e7ed7289e 61 fields · synced May 19, 2026
- EUDAMED 4d687457-0757-498e-86d8-fa8ad287bc81 61 fields · synced May 19, 2026