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Heat and moisture exchange filter
EUDAMEDClass IIa (EU MDR)
Ref ZF-233Model MHG-S\MHG-HM\MHG-HXT
Identity
- Trade Name
- Heat and moisture exchange filter EUDAMED
- Device Name
- Heat and moisture exchange filter EUDAMED
- Model / Reference
- MHG-S\MHG-HM\MHG-HXT EUDAMEDZF-233 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970529956106 EUDAMED
- Basic UDI-DI
- 697052995HMEF001SG EUDAMED
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Heat and moisture exchange filter by Shandong Zhenfu Medical Device 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 | 697052995HMEF001SG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shandong Zhenfu Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000031319
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED a0c1a7ee-fc51-4129-bd3e-43ecd83c0558 61 fields · synced Jun 19, 2026