Identity
- Trade Name
- HME filter EUDAMED
- Device Name
- Heat and moisture exchange filter EUDAMED
- Model / Reference
- MHG-S ZF-0625 EUDAMED613 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970529956137 EUDAMED
- Basic UDI-DI
- B-16970529956137 EUDAMED
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HME filter by Shandong Zhenfu Medical Device Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16970529956137 | Class I | 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 2e48fdb2-47d5-4429-8d98-c7a025e78d06 61 fields · synced Jun 18, 2026