← Back to catalogue
Silicone Tracheostomy Tube, Low Pressure Cuff
EUDAMEDClass IIb (EU MDR)
Ref 1565-0070Ref 1565-0060Ref 1561-0085Ref 1565-0085Ref 1565-0080Ref 1565-0100Ref 1565-0055Ref 1565-0095Ref 1565-0075Ref 1565-0050
Identity
- Trade Name
- Silicone Tracheostomy Tube, Low Pressure Cuff EUDAMEDSilicone Tracheostomy Tube EUDAMED
- Device Name
- Silicone Tracheostomy Tube, Low Pressure Cuff EUDAMEDSilicone Tracheostomy Tube EUDAMED
- Model / Reference
- 1565-0070 EUDAMED1565-0060 EUDAMED1561-0085 EUDAMED1565-0085 EUDAMED1565-0080 EUDAMED1565-0100 EUDAMED1565-0055 EUDAMED1565-0095 EUDAMED1565-0075 EUDAMED1565-0050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14710961931109 EUDAMED14710961931093 EUDAMED04711182628444 EUDAMED04711182628390 EUDAMED04710961931119 EUDAMED14710961931130 EUDAMED04711182628420 EUDAMED14711182628441 EUDAMED04711182628383 EUDAMED04711182628406 EUDAMED04710961931102 EUDAMED04710961931089 EUDAMED
- Basic UDI-DI
- B-14710961931109 EUDAMEDB-14710961931093 EUDAMEDB-04711182628444 EUDAMEDB-04711182628390 EUDAMEDB-04710961931119 EUDAMEDB-14710961931130 EUDAMEDB-04711182628420 EUDAMEDB-14711182628441 EUDAMEDB-04711182628383 EUDAMEDB-04711182628406 EUDAMEDB-04710961931102 EUDAMEDB-04710961931089 EUDAMED
- EMDN Code
- R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMEDR0105010101 TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMEDFinland 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: Tracheostomy tube, non-reinforced, non-customized, single-use
Silicone Tracheostomy Tube, Low Pressure Cuff by Fortune Medical Instrument Corp. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube, non-reinforced, non-customized, single-use.
- Shiley — Covidien LP · Class II
- TRACOE mini — Tracoe medical GmbH · Class II
- PRIMEDISILK® Silikonkanüle, Gr.10 Länge 62 mm ohne Konnektor — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Tracheal Stent with Mesh and Posts — HOOD, E BENSON LABORATORIES INC · Class II
- Trachealkanüle PRIMEDISTOM®, Gr.10, L = 85 mm — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Shiley — Covidien LP · Class II
- Trachealkanüle Ultrasoft Suction Gr.8 — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Silber Innenkanüle mit Adaptionsring für rundes Kastenventil gesiebt — Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH · Class IIb
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-14710961931109 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (12)
- EUDAMED 1884135b-9544-44c8-ba17-7f198bc2c5a5 61 fields · synced Aug 4, 2026
- EUDAMED 7558901a-4517-457f-945f-a28d9b8eebaa 61 fields · synced May 11, 2026
- EUDAMED d3e33cab-5f13-437f-9567-6337d17e9b86 61 fields · synced May 11, 2026
- EUDAMED e38a8aa5-7950-4b25-b456-0e2a15dc434d 61 fields · synced May 16, 2026
- EUDAMED 77a89024-aa22-4f0d-8ba8-15fa99e040f1 61 fields · synced May 17, 2026
- EUDAMED 30c408e5-35c1-4952-9fde-546395904c98 61 fields · synced May 17, 2026
- EUDAMED 14ada114-ee7a-42b9-bdfa-204e4d00dcf8 61 fields · synced May 17, 2026
- EUDAMED afc31152-7071-4b19-ba39-a1a3f636b31f 61 fields · synced May 17, 2026
- EUDAMED 12441185-999a-4a7f-9819-e173a95eef8e 61 fields · synced May 18, 2026
- EUDAMED b5ffbc0e-f267-4dd6-a729-41ec5d8d12a5 61 fields · synced May 18, 2026
- EUDAMED 8ee52517-f9bb-43f3-9c7a-28b8e1b8df53 61 fields · synced May 18, 2026
- EUDAMED 4e180d57-8c48-43b8-a06a-a3256cb34f07 61 fields · synced May 19, 2026