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Et Tube
EUDAMEDClass IIa (EU MDR)
Ref HET01-100MModel ET TUBE WITH CUFFEDRef HET01-50MRef HET01-90MRef HET01-65MRef HET01-80MRef HET01-40MRef HET01-95MRef HET01-20Model ET Tube without cuffed
Identity
- Trade Name
- ET TUBE EUDAMED
- Device Name
- Disposable Tracheal Tubes（Standard） EUDAMED
- Model / Reference
- ET TUBE WITH CUFFED EUDAMEDHET01-100M EUDAMEDHET01-50M EUDAMEDHET01-90M EUDAMEDHET01-65M EUDAMEDHET01-80M EUDAMEDHET01-40M EUDAMEDHET01-95M EUDAMEDET Tube without cuffed EUDAMEDHET01-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970304313448 EUDAMED06970304313585 EUDAMED06970304313806 EUDAMED06970304313660 EUDAMED06970304313752 EUDAMED06970304313547 EUDAMED06970304313837 EUDAMED06970304313462 EUDAMED
- Basic UDI-DI
- 697030431220600049E EUDAMED697030431231100258V EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMEDR01030101 ENDOTRACHEAL TUBES, CUFFLESS, 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 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 | 697030431220600049E | 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 (8)
- EUDAMED aacb010f-0c89-4963-bd34-81ff62154865 61 fields · synced Aug 2, 2026
- EUDAMED 82a0f333-5262-4842-a082-52fd8a076658 61 fields · synced May 16, 2026
- EUDAMED 22d5bac8-1a18-478c-b50b-0d31664b7e2d 61 fields · synced May 17, 2026
- EUDAMED 054a07e9-c902-4490-807c-07824102a35f 61 fields · synced May 18, 2026
- EUDAMED f0b904e6-7985-4642-a0ee-45db8ce6f516 61 fields · synced May 18, 2026
- EUDAMED ee3f95d0-466a-4f1a-81a8-60afb64cbcaa 61 fields · synced May 18, 2026
- EUDAMED f556a30d-896d-4034-a703-1a3e35d3ea01 61 fields · synced May 19, 2026
- EUDAMED e9a0f6a5-76b5-4d08-a542-6ad568431988 61 fields · synced May 19, 2026