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Breath filter
EUDAMEDClass I (EU MDR)
Ref SV-EBFNRef SV-IBFHRef SV-EBFTModel SV-HNBFRef SV-EBFH
Identity
- Device Name
- Breath filter EUDAMED
- Model / Reference
- SV-EBFN EUDAMEDSV-IBFH EUDAMEDSV-EBFT EUDAMEDSV-HNBF EUDAMEDSV-EBFH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971022541205 EUDAMED06971022541151 EUDAMED06971022541229 EUDAMED06971022541243 EUDAMED06971022540840 EUDAMED
- Basic UDI-DI
- 6971022SUNVOU01728 EUDAMED6971022SUNVOU00725 EUDAMED6971022SUNVOU0192C EUDAMED6971022SUNVOU0182A EUDAMED6971022SUNVOU00623 EUDAMED
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Microbial Substances
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Breath filter by Sunvou Medical Electronics Co., Ltd. — Class I — IVDR, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6971022SUNVOU01728 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6971022SUNVOU01728 | Class I | Active |
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Manufacturer
- Manufacturer
- Sunvou Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000004543
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (5)
- EUDAMED 5eca3335-39e6-47e0-9fae-ec4c65632307 61 fields · synced Jul 14, 2026
- EUDAMED 30b38c79-4447-4cd5-9bd2-e1f6321fd0ed 61 fields · synced May 16, 2026
- EUDAMED 487610a4-ae01-4e6c-90c1-65b5a582500f 61 fields · synced May 17, 2026
- EUDAMED 9fbd5b9e-f875-48e9-aec2-3682a0cb09ec 61 fields · synced May 17, 2026
- EUDAMED eb8d78c2-c581-4f77-84d1-9aa4827e05c6 61 fields · synced May 18, 2026