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Silicone Tracheostomy Tube, Low Pressure Cuff
EUDAMEDClass IIb (EU MDR)
Ref 1565-0100
Identity
- Trade Name
- Silicone Tracheostomy Tube, Low Pressure Cuff EUDAMED
- Device Name
- Silicone Tracheostomy Tube, Low Pressure Cuff EUDAMED
- Model / Reference
- 1565-0100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961931133 EUDAMED
- Basic UDI-DI
- B-04710961931133 EUDAMED
- EMDN Code
- R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Silicone Tracheostomy Tube, Low Pressure Cuff by Fortune Medical Instrument Corp. — Class IIb — 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-04710961931133 | Class IIb | 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 fbfa3cae-4566-4aa5-bd72-a895a1038d60 61 fields · synced Jun 18, 2026