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Tracheobronxane Dumon
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 03081S
by Novatech Sa
Identity
- Trade Name
- TRACHEOBRONXANE DUMON EUDAMEDTRACHEOBRONXANE™ DUMON® FDA UDI
- Generic Name
- Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
- Device Name
- Tracheobronchial Stent EUDAMEDTracheo-bronchial silicone stent, TD 11 L 60 FDA UDI
- Model / Reference
- 03081S EUDAMEDFDA UDI
- Description
- Tracheo-bronchial silicone stent, TD 11 L 60 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14063108100051 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14063108100051 EUDAMED
- 510(k) Number
- K243126 FDA UDI
- FDA Product Code
- NWA FDA UDI
- EMDN Code
- P0401 TRACHEOBRONCHIAL PROSTHESES EUDAMED
- GMDN Term
- Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3720 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Tracheobronxane Dumon by Novatech Sa — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243126 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-14063108100051 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Novatech Sa
- EUDAMED SRN
- FR-MF-000001658
Sources (3)
- EUDAMED 62521880-f7ca-4fd2-862f-01677fee55c1 61 fields · synced Jul 20, 2026
- FDA UDI 58152e44-e6d8-4769-a47f-5edcd27b036d 34 fields · synced May 30, 2026
- FDA 510(k) K243126 1 fields · synced May 18, 2026