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Slllcone Tracheostomy Tube, Ordinary Cuff
EUDAMEDClass IIb (EU MDR)
Ref 1560-0070
Identity
- Trade Name
- Slllcone Tracheostomy Tube, Ordinary Cuff EUDAMED
- Device Name
- Slllcone Tracheostomy Tube, Ordinary Cuff EUDAMED
- Model / Reference
- 1560-0070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961930983 EUDAMED
- Basic UDI-DI
- B-04710961930983 EUDAMED
- EMDN Code
- R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria 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
Slllcone Tracheostomy Tube, Ordinary 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-04710961930983 | 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 a1c971ab-ae26-425a-a125-3fd1f2ff52ec 61 fields · synced Jun 18, 2026