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Slllcone Tracheostomy Tube, Ordinary Cuff
EUDAMEDClass IIb (EU MDR)
Ref 1560-0090Ref 1560-0085Ref 1561-0070
Identity
- Trade Name
- Slllcone Tracheostomy Tube, Ordinary Cuff EUDAMEDSlllcone Tracheostomy Tube EUDAMED
- Device Name
- Slllcone Tracheostomy Tube, Ordinary Cuff EUDAMEDSlllcone Tracheostomy Tube EUDAMED
- Model / Reference
- 1560-0090 EUDAMED1560-0085 EUDAMED1561-0070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961931003 EUDAMED04711182628499 EUDAMED04710961931041 EUDAMED
- Basic UDI-DI
- B-04710961931003 EUDAMEDB-04711182628499 EUDAMEDB-04710961931041 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
- Bulgaria 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
Slllcone Tracheostomy Tube, Ordinary Cuff by Fortune Medical Instrument Corp. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tracheostomy tube, non-reinforced, non-customized, single-use.
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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-04710961931003 | 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 (3)
- EUDAMED 7dee53fd-413f-44f1-b081-993a42daaa09 61 fields · synced Jul 15, 2026
- EUDAMED 27599331-4a2f-4f90-9c68-122efbe7beb2 61 fields · synced May 19, 2026
- EUDAMED 8dae0853-8e3b-4be3-a135-ec797a265fe8 61 fields · synced May 19, 2026