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Silicone Endotracheal Tube
EUDAMEDClass IIa (EU MDR)
Ref 1555-0075Ref 1555-0070
Identity
- Trade Name
- Silicone Endotracheal Tube EUDAMED
- Device Name
- Silicone Endotracheal Tube EUDAMED
- Model / Reference
- 1555-0075 EUDAMED1555-0070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14710961930904 EUDAMED14710961930898 EUDAMED
- Basic UDI-DI
- B-14710961930904 EUDAMEDB-14710961930898 EUDAMED
- EMDN Code
- R01030202 ENDOTRACHEAL TUBES, CUFFED, 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
Category: Reinforced endotracheal tube, single-use
Silicone Endotracheal Tube by Fortune Medical Instrument Corp. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Reinforced endotracheal tube, single-use.
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- Welllead Reinforced Tracheal Tube — Well Lead Medical Co., Ltd · Class IIa
- Disposable Endotracheal Tubes — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Endotracheal Tube — HANGZHOU FORMED MEDICAL DEVICES CO., LTD. · Class IIa
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-14710961930904 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 9dd87b8a-2d08-4d5a-9372-eb1c8c5987d9 61 fields · synced Jul 9, 2026
- EUDAMED b9d7c24b-05a1-4a79-be88-f59f2de1d64e 61 fields · synced May 18, 2026