Identity
- Trade Name
- "Fortune" Tracheal Tube Fixation Device EUDAMED
- Device Name
- "Fortune" Tracheal Tube Fixation Device EUDAMED
- Model / Reference
- 1500-0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182628895 EUDAMED
- Basic UDI-DI
- 471096193001401F2 EUDAMED
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
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
"Fortune" Tracheal Tube Fixation Device by Fortune Medical Instrument Corp. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 471096193001401F2 | Class I | 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 (1)
- EUDAMED 96d27a1d-79e5-4105-9e9c-0cfc50c6a717 61 fields · synced Jul 9, 2026