Identity
- Trade Name
- oxygen mask nebulizer type EUDAMED
- Device Name
- Oxygen mask nebulizer type S EUDAMED
- Model / Reference
- HK-D02-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945934603405 EUDAMED
- Basic UDI-DI
- B-06945934603405 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
oxygen mask nebulizer type by Changzhou Huankang Medical Device 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-06945934603405 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Huankang Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000009030
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 56b23e77-7cd0-48d5-94b4-03fba61d60d8 61 fields · synced Oct 5, 2026