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Nasal Oxygen Cannula
EUDAMEDClass IIa (EU MDR)
Ref HK-C08-XS, HK-C08-S, HK-C08-M, HK-C08-LRef HK-C08-LModel HK-C08-L
Identity
- Trade Name
- Nasal Oxygen Cannula EUDAMED
- Device Name
- Nasal Oxygen Cannulae EUDAMEDnasal oxygen cannula size: Adult EUDAMED
- Model / Reference
- HK-C08-XS, HK-C08-S, HK-C08-M, HK-C08-L EUDAMEDHK-C08-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69459346HKC08TBU4 EUDAMED06945934602330 EUDAMED
- Basic UDI-DI
- B-69459346HKC08TBU4 EUDAMEDB-06945934602330 EUDAMED
- EMDN Code
- R03010280 OXYGEN THERAPY MASKS AND NASAL CANNULAS - ACCESSORIES EUDAMEDR0301020301 OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMEDBulgaria 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
Nasal Oxygen Cannula 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-69459346HKC08TBU4 | 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 8f6cc488-1674-4ebc-9c26-ff78888692fa 61 fields · synced Oct 6, 2026
- EUDAMED 8f6cc488-1674-4ebc-9c26-ff78888692fa-1 61 fields · synced Jun 9, 2026
- EUDAMED e546c37b-7f29-432d-8e69-c63c1f1badf5 61 fields · synced Jul 16, 2026