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oxygen concentrator filter
EUDAMEDClass I (EU MDR)
Ref ZF-055Model MHG-J ZF-055Ref ZF-086Model MHG-F Ref ZF-054Model MHG-F
Identity
- Trade Name
- oxygen concentrator filter EUDAMED
- Device Name
- oxygen concentrator filter EUDAMEDBacterial viral filter EUDAMED
- Model / Reference
- MHG-J ZF-055 EUDAMEDZF-055 EUDAMEDMHG-F EUDAMEDZF-086 EUDAMEDZF-054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970529950951 EUDAMED16970529950982 EUDAMED16970529950975 EUDAMED
- Basic UDI-DI
- B-16970529950951 EUDAMED697052995BVF001K5 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMEDR040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Germany EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
No
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
oxygen concentrator 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-16970529950951 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-16970529950951 | 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 (3)
- EUDAMED bfc34ca4-3ef8-4283-8441-f0928208b893 61 fields · synced Jul 30, 2026
- EUDAMED 38d34efa-7e74-41ce-a759-48ff06ec07e2 61 fields · synced May 18, 2026
- EUDAMED 803c5034-9153-4fe7-9f15-f71006393caf 61 fields · synced May 18, 2026