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Disposable Heat and Moisture Exchanger Filters
EUDAMEDClass IIa (EU MDR)
Ref A1 3001Model HMEF2
Identity
- Trade Name
- Disposable Heat and Moisture Exchanger Filters EUDAMED
- Device Name
- Disposable Heat and Moisture Exchanger Filters EUDAMED
- Model / Reference
- HMEF2 EUDAMEDA1 3001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941850827673 EUDAMED
- Basic UDI-DI
- 69418508HMEF2R7 EUDAMED
- EMDN Code
- R040199 VENTILATION FILTERS - OTHER 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
No
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
Category: Microbial medical gas filter, single-use
Disposable Heat and Moisture Exchanger Filters by Ningbo Huakun Medical Equipment Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Microbial medical gas filter, single-use.
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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 | 69418508HMEF2R7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Huakun Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008459
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 5d2c39d9-3662-4839-bcca-76ad9be90b96 61 fields · synced Jul 13, 2026