Identity
- Trade Name
- Breathing System Filter(HMEF) EUDAMED
- Device Name
- Breathing System Filter(HMEF) EUDAMED
- Model / Reference
- HME204S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-HME204ST4 EUDAMED
- Basic UDI-DI
- B-HME204ST4 EUDAMED
- EMDN Code
- R040299 NATURAL BREATHING 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
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
Breathing System Filter(HMEF) by Hangzhou Tappa Medical Technology Co , Ltd. — Class IIa — 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-HME204ST4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Tappa Medical Technology Co , Ltd.
- EUDAMED SRN
- CN-MF-000027753
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED ebd7141d-34a3-4bcd-af67-012913d7b98e 61 fields · synced Jun 18, 2026