Identity
- Trade Name
- Endobronchial Blocker Tube EUDAMED
- Device Name
- Endobronchial Blocker Tube EUDAMED
- Model / Reference
- EBT0109S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EBT0109S7T EUDAMED
- Basic UDI-DI
- B-EBT0109S7T EUDAMED
- EMDN Code
- R010499 ONE LUNG VENTILATION DEVICES (OLV) - OTHER 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
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
Endobronchial Blocker Tube by Hangzhou Tappa Medical Technology 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-EBT0109S7T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Tappa Medical Technology Co , Ltd.
- EUDAMED SRN
- CN-MF-000027753
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 10486656-645b-47ce-bdad-f41e3380bbd5 61 fields · synced Oct 5, 2026