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Disposable HMEF breathing filter
EUDAMEDClass I (EU MDR)
Ref 605Model MHG-S ZF-218Ref 606Model MHG-S ZF-233
Identity
- Trade Name
- Disposable HMEF breathing filter EUDAMED
- Device Name
- Heat and moisture exchange filter EUDAMED
- Model / Reference
- MHG-S ZF-218 EUDAMED605 EUDAMEDMHG-S ZF-233 EUDAMED606 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970529956052 EUDAMED16970529956069 EUDAMED
- Basic UDI-DI
- B-16970529956052 EUDAMEDB-16970529956069 EUDAMED
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Disposable HMEF breathing 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-16970529956052 | 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 (2)
- EUDAMED 3b96941b-7f13-411e-95b1-abe24704252b 61 fields · synced Jul 16, 2026
- EUDAMED 24159b5c-24b1-482e-a28c-2672afa60375 61 fields · synced May 17, 2026