Identity
- Trade Name
- endotracheal tube normal uncuffed EUDAMED
- Device Name
- endotracheal tube, normal, uncuffed EUDAMED
- Model / Reference
- HK-E01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945934603061 EUDAMED
- Basic UDI-DI
- B-06945934603061 EUDAMED
- EMDN Code
- R01030101 ENDOTRACHEAL TUBES, CUFFLESS, NOT REINFORCED 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
endotracheal tube normal uncuffed 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-06945934603061 | 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 2ed07c1d-8db3-4b59-a01f-295a5d88f245 61 fields · synced Jun 19, 2026