Identity
- Trade Name
- Heated Humidifier EUDAMED
- Device Name
- Heated Humidifier EUDAMED
- Model / Reference
- H60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538362006 EUDAMED
- Basic UDI-DI
- 69485383HH001Q6 EUDAMED
- Direct Marketing DI
- 06948538362006 EUDAMED
- EMDN Code
- R060201 ACTIVE VENTILATION 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
Heated Humidifier by BMC Medical 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 | 69485383HH001Q6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BMC Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000010157
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e022bef7-7de8-439e-b495-6447e5b1ddda 61 fields · synced May 23, 2026