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Respircare High-Flow Heated Respiratory Humidifiers
EUDAMEDClass IIa (EU MDR)
Ref HUMID-R9A
Identity
- Trade Name
- Respircare High-Flow Heated Respiratory Humidifiers EUDAMED
- Device Name
- High-Flow Heated Respiratory Humidifiers EUDAMED
- Model / Reference
- HUMID-R9A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957469401647 EUDAMED
- Basic UDI-DI
- 6957469402030DX EUDAMED
- Direct Marketing DI
- 06957469401647 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 | 6957469402030DX | 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 (1)
- EUDAMED 222a3672-e8e1-454a-8d8b-4cdc82116089 61 fields · synced Jun 18, 2026