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Heat and moisture exchange filter
EUDAMEDClass I (EU MDR)
Ref ZF-001Model MHG-S ZF-001Ref 616Model MHG-F Ref ZF-302Model MHG-S ZF-302Ref /Model MHG-S ZF-218
Identity
- Trade Name
- Heat and moisture exchange filter EUDAMED
- Device Name
- Heat and moisture exchange filter EUDAMEDBacterial viral filter EUDAMED
- Model / Reference
- MHG-S ZF-001 EUDAMEDZF-001 EUDAMEDMHG-F EUDAMED616 EUDAMEDMHG-S ZF-302 EUDAMEDZF-302 EUDAMEDMHG-S ZF-218 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970529951029 EUDAMED16970529956168 EUDAMED06970529951234 EUDAMED06970529951128 EUDAMED
- Basic UDI-DI
- B-06970529951029 EUDAMED697052995BVF001K5 EUDAMEDB-06970529951234 EUDAMEDB-06970529951128 EUDAMED
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMEDR040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Germany EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
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 I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06970529951029 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06970529951029 | 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 (4)
- EUDAMED eb2680db-3ae9-47a5-b7d9-baf60034067c 61 fields · synced Jul 31, 2026
- EUDAMED bce609c6-06d3-4058-9d26-a215a90c7447 61 fields · synced May 17, 2026
- EUDAMED cf036bdd-ec00-413b-8d94-552ce6bb0740 61 fields · synced May 18, 2026
- EUDAMED 793cc0f8-c977-40b3-96d8-a09070913292 61 fields · synced May 18, 2026