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Et Tube Combo
EUDAMEDClass IIa (EU MDR)
Ref HET01-65M-SETModel cuff conmboRef HET01-75M-SETRef HET01-95M-SETRef HET01-80M-SETRef HET01-70M-SETRef HET01-60M-SETRef HET01-55M-SET
Identity
- Trade Name
- ET TUBE COMBO EUDAMED
- Device Name
- Disposable Tracheal Tubes（Standard） EUDAMED
- Model / Reference
- cuff conmbo EUDAMEDHET01-65M-SET EUDAMEDHET01-75M-SET EUDAMEDHET01-95M-SET EUDAMEDHET01-80M-SET EUDAMEDHET01-70M-SET EUDAMEDHET01-60M-SET EUDAMEDHET01-55M-SET EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970304313677 EUDAMED06970304313738 EUDAMED06970304316104 EUDAMED06970304313769 EUDAMED06970304313707 EUDAMED06970304313646 EUDAMED06970304313615 EUDAMED
- Basic UDI-DI
- 6970304312311002893 EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Basic endotracheal tube, single-use
Et Tube Combo by Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Basic endotracheal tube, single-use.
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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 | 6970304312311002893 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.
- EUDAMED SRN
- CN-MF-000002179
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (7)
- EUDAMED 0d31569b-070a-4f68-9573-ca8874cada0e 61 fields · synced Jul 20, 2026
- EUDAMED 67ba29dd-002c-4bba-8f57-1ac109eb7d3d 61 fields · synced May 17, 2026
- EUDAMED f2532027-9625-4edc-a4b4-dd598b3f6240 61 fields · synced May 17, 2026
- EUDAMED 5ea9adce-cd09-477c-9a2f-e1d9a1d236d3 61 fields · synced May 17, 2026
- EUDAMED ffa5ff1f-186e-42ca-a552-f97fe21146e5 61 fields · synced May 18, 2026
- EUDAMED 6af05303-efbb-407c-ad39-2e3dc6abba34 61 fields · synced May 18, 2026
- EUDAMED aca9ea65-6034-4004-9109-be72e33e97b7 61 fields · synced May 19, 2026