Identity
- Device Name
- Breath filter EUDAMED
- Model / Reference
- SV-NBFH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971022541212 EUDAMED
- Basic UDI-DI
- 6971022SUNVOU01524 EUDAMED
- EMDN Code
- R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Breath filter by Sunvou Medical Electronics Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6971022SUNVOU01524 | 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 (1)
- EUDAMED ffbfa7e1-7bb9-4ad3-83dd-f1751371be99 61 fields · synced Jun 19, 2026