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Oxygen Mask
EUDAMEDClass IIa (EU MDR)
Ref HK-D01-XS, HK-D01-S, HK-D01-M, HK-D01-L, HK-D01-XLRef HK-D01-S
Identity
- Trade Name
- Oxygen Mask EUDAMED
- Device Name
- Oxygen Mask EUDAMED
- Model / Reference
- HK-D01-XS, HK-D01-S, HK-D01-M, HK-D01-L, HK-D01-XL EUDAMEDHK-D01-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69459346HKD01T2SE EUDAMED06945934603436 EUDAMED
- Basic UDI-DI
- B-69459346HKD01T2SE EUDAMEDB-06945934603436 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN 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 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-69459346HKD01T2SE | 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 (3)
- EUDAMED b9aea232-eca9-4087-a3d4-1f0e9ad9886a 61 fields · synced Oct 7, 2026
- EUDAMED b9aea232-eca9-4087-a3d4-1f0e9ad9886a-1 61 fields · synced Jun 11, 2026
- EUDAMED 2924da91-8a46-481c-8415-f22c8e908c9a 61 fields · synced Jun 20, 2026