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Tracheostomy HME filter
EUDAMEDClass IIa (EU MDR)
Ref ZF-302Model MHG-S\MHG-HM\MHG-HXT
Identity
- Trade Name
- Tracheostomy HME filter EUDAMED
- Device Name
- Heat and moisture exchange filter EUDAMED
- Model / Reference
- MHG-S\MHG-HM\MHG-HXT EUDAMEDZF-302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970529956113 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
Tracheostomy HME 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 8d872cd4-8c99-4cb6-89e2-2b4ec6cb0461 61 fields · synced Sep 17, 2026