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Respircare High-Flow Heated Respiratory Humidifiers
EUDAMEDClass IIa (EU MDR)
Ref HUMID-BMRef HUMID-R8Ref HUMID-R10ARef HUMID-BH90 Ref HUMID-BHR Ref HUMID-R8ARef HUMID-BHRef HUMID-R10
Identity
- Trade Name
- Respircare High-Flow Heated Respiratory Humidifiers EUDAMED
- Device Name
- High-Flow Heated Respiratory Humidifiers EUDAMED
- Model / Reference
- HUMID-BM EUDAMEDHUMID-R8 EUDAMEDHUMID-R10A EUDAMEDHUMID-BH90 EUDAMEDHUMID-BHR EUDAMEDHUMID-R8A EUDAMEDHUMID-BH EUDAMEDHUMID-R10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957469402361 EUDAMED06957469401616 EUDAMED06957469401654 EUDAMED06957469401111 EUDAMED06957469402354 EUDAMED06957469401623 EUDAMED06957469402347 EUDAMED06957469401661 EUDAMED
- Basic UDI-DI
- 6957469402032E3 EUDAMED6957469402030DX EUDAMED6957469402031DZ EUDAMED
- Direct Marketing DI
- 06957469402361 EUDAMED06957469401616 EUDAMED06957469401654 EUDAMED06957469401111 EUDAMED06957469402354 EUDAMED06957469401623 EUDAMED06957469402347 EUDAMED06957469401661 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS 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
Respircare High-Flow Heated Respiratory Humidifiers 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 | 6957469402032E3 | 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 (8)
- EUDAMED c70e8b30-b39e-4d9a-829f-db31e020f728 61 fields · synced Jul 25, 2026
- EUDAMED faae499c-6292-480b-ba71-a01102b0b59a 61 fields · synced May 17, 2026
- EUDAMED 3d30b5a1-987c-435f-ad2a-f290fe525bf4 61 fields · synced May 17, 2026
- EUDAMED 63363dfa-19f0-4b47-ba9e-0fb8aa374025 61 fields · synced May 17, 2026
- EUDAMED 3223084d-6df8-4744-b1c3-27ed4644b818 61 fields · synced May 17, 2026
- EUDAMED 066f6d47-f3d9-42c7-a6f7-024b0f08bc63 61 fields · synced May 17, 2026
- EUDAMED f53a672c-34bf-4c76-bf68-d36b78aa8234 61 fields · synced May 18, 2026
- EUDAMED c4740021-2346-4f53-b85b-a41c7ddfaf76 61 fields · synced May 18, 2026