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Humidification Chamber
EUDAMEDClass IIa (EU MDR)
Ref HF1104Model HF1101,HF1103,HF1104Ref HF1101
Identity
- Trade Name
- Humidification Chamber EUDAMED
- Device Name
- Humidification Chamber EUDAMED
- Model / Reference
- HF1101,HF1103,HF1104 EUDAMEDHF1104 EUDAMEDHF1101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06903053054799 EUDAMED06903053041300 EUDAMED
- Basic UDI-DI
- 69449040AB0200004545 EUDAMED
- EMDN Code
- R060280 HUMIDIFICATION SYSTEMS - ACCESSORIES 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tracheostomy tube speech valve
Humidification Chamber by Shenzhen Mindray Bio-Medical Electronics Co., LTD — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69449040AB0200004545 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 39070c29-2864-49e0-b1d9-c0eab22ac04c 61 fields · synced Jul 29, 2026
- EUDAMED 87ad6b2d-ce98-4529-a831-20c5a9bb30c8 61 fields · synced May 18, 2026