← Back to catalogue
Tracheobronchial Stent
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 03321S
by Novatech Sa
Identity
- Trade Name
- TRACHEOBRONXANE™ DUMON® FDA UDI
- Generic Name
- Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
- Device Name
- Tracheobronchial Stent EUDAMEDTracheo-bronchial silicone stent, TD 13 L 60 FDA UDI
- Model / Reference
- 03321S EUDAMEDFDA UDI
- Description
- Tracheo-bronchial silicone stent, TD 13 L 60 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14063108106350 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14063108106350 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
Tracheobronchial Stent by Novatech Sa — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-14063108106350 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novatech Sa
- EUDAMED SRN
- FR-MF-000001658
Sources (2)
- EUDAMED c29ee004-8376-4f04-a410-7cc1d4c6c19f 61 fields · synced Jun 19, 2026
- FDA UDI 47026a7b-6594-47af-83e8-e82c8122e470 34 fields · synced May 30, 2026