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Tracheobronxane Dumon
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 03201SModel Tracheobronchial StentRef 03341FSRef 03261FSRef 03661SRef 03701SRef 03421SRef 03551SRef 03281FSRef 03561SRef 03161FSRef 03571SRef 03441SRef 03461SRef 03341S
by Novatech Sa
Identity
- Trade Name
- TRACHEOBRONXANE DUMON EUDAMEDTRACHEOBRONXANE™ DUMON® FDA UDI
- Generic Name
- Polymeric tracheal/bronchial stent, non-bioabsorbable FDA UDI
- Device Name
- TRACHEOBRONXANE DUMON EUDAMEDTracheo-bronchial silicone stent, TF 13 L 70 FDA UDITracheo-bronchial silicone stent, TD 15 L 70 FDA UDITracheo-bronchial silicone stent, TD 12 L 60 FDA UDITracheo-bronchial silicone stent, TD 16 L 50 FDA UDITracheo-bronchial silicone stent, TD 16 L 70 FDA UDITracheo-bronchial silicone stent, TF 12 L 40 FDA UDITracheo-bronchial silicone stent, TD 15 L 50 FDA UDITracheo-bronchial silicone stent, TD 14 L 60 FDA UDITracheo-bronchial silicone stent, TD 14 L 50 FDA UDITracheo-bronchial silicone stent, TD 14 L 70 FDA UDITracheo-bronchial silicone stent, TF 13 L 40 FDA UDITracheo-bronchial silicone stent, TD 15 L 60 FDA UDITracheo-bronchial silicone stent, TD 13 L 70 FDA UDITracheo-bronchial silicone stent, TF 13 L 30 FDA UDI
- Model / Reference
- Tracheobronchial Stent EUDAMED03201S EUDAMEDFDA UDI03341FS EUDAMEDFDA UDI03571S EUDAMEDFDA UDI03661S EUDAMEDFDA UDI03701S EUDAMEDFDA UDI03161FS EUDAMEDFDA UDI03551S EUDAMEDFDA UDI03441S EUDAMEDFDA UDI03421S EUDAMEDFDA UDI03461S EUDAMEDFDA UDI03281FS EUDAMEDFDA UDI03561S EUDAMEDFDA UDI03341S EUDAMEDFDA UDI03261FS EUDAMEDFDA UDI
- Description
- Tracheo-bronchial silicone stent, TF 13 L 70 FDA UDITracheo-bronchial silicone stent, TD 15 L 70 FDA UDITracheo-bronchial silicone stent, TD 12 L 60 FDA UDITracheo-bronchial silicone stent, TD 16 L 50 FDA UDITracheo-bronchial silicone stent, TD 16 L 70 FDA UDITracheo-bronchial silicone stent, TF 12 L 40 FDA UDITracheo-bronchial silicone stent, TD 15 L 50 FDA UDITracheo-bronchial silicone stent, TD 14 L 60 FDA UDITracheo-bronchial silicone stent, TD 14 L 50 FDA UDITracheo-bronchial silicone stent, TD 14 L 70 FDA UDITracheo-bronchial silicone stent, TF 13 L 40 FDA UDITracheo-bronchial silicone stent, TD 15 L 60 FDA UDITracheo-bronchial silicone stent, TD 13 L 70 FDA UDITracheo-bronchial silicone stent, TF 13 L 30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14063108100112 EUDAMEDFDA UDI14063108100525 EUDAMEDFDA UDI14063108100303 EUDAMEDFDA UDI14063108100372 EUDAMEDFDA UDI14063108100396 EUDAMEDFDA UDI14063108100464 EUDAMEDFDA UDI14063108100280 EUDAMEDFDA UDI14063108100242 EUDAMEDFDA UDI14063108100235 EUDAMEDFDA UDI14063108100259 EUDAMEDFDA UDI14063108100495 EUDAMEDFDA UDI14063108100297 EUDAMEDFDA UDI14063108100198 EUDAMEDFDA UDI14063108100488 EUDAMEDFDA UDI
- Basic UDI-DI
- B-14063108100112 EUDAMEDB-14063108100525 EUDAMEDB-14063108100488 EUDAMEDB-14063108100372 EUDAMEDB-14063108100396 EUDAMEDB-14063108100235 EUDAMEDB-14063108100280 EUDAMEDB-14063108100495 EUDAMEDB-14063108100297 EUDAMEDB-14063108100464 EUDAMEDB-14063108100303 EUDAMEDB-14063108100242 EUDAMEDB-14063108100259 EUDAMEDB-14063108100198 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 — 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-14063108100112 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Novatech Sa
- EUDAMED SRN
- FR-MF-000001658
Sources (28)
- EUDAMED c652b757-1219-4398-b70f-6fd53c351e6e 61 fields · synced Aug 2, 2026
- FDA UDI a07632a1-9d62-4973-a5a9-538e90ec2907 34 fields · synced May 27, 2026
- FDA UDI d36a9e2b-8764-4d2d-810f-20b10f46b7a1 34 fields · synced May 29, 2026
- FDA UDI fb630b78-1b7d-4b01-be6a-eaf72008544b 34 fields · synced May 29, 2026
- FDA UDI cdf26f5d-05b8-4823-8f65-e46832830386 34 fields · synced May 30, 2026
- FDA UDI e7939012-8e2e-476b-8208-4de2bed16247 34 fields · synced May 30, 2026
- FDA UDI 714538da-7d42-44e1-8435-fb86393a1b24 34 fields · synced May 30, 2026
- FDA UDI 713b58b7-74ed-419f-bc66-5e731c47abb2 34 fields · synced May 30, 2026
- FDA UDI f0233049-2ea8-4b6b-8feb-b63eb5ea7287 34 fields · synced May 30, 2026
- FDA UDI 52b6b6e8-ba33-492d-ab6a-39ac460fd876 34 fields · synced May 30, 2026
- FDA UDI 6c220df9-4219-4446-bb92-f58fc32f0fb5 34 fields · synced May 30, 2026
- FDA UDI e23a89e3-dbb4-44c6-9ca3-8d98e0b49ae3 34 fields · synced May 30, 2026
- FDA UDI 02e12c66-4bf3-4f91-89c1-8a1247b32eeb 34 fields · synced May 30, 2026
- FDA UDI 5caf1679-a6ce-4983-9fd1-286e3272bc1b 34 fields · synced May 30, 2026
- FDA UDI 4bd845a9-a9c3-4467-bfc3-4efc870ca424 34 fields · synced May 30, 2026
- EUDAMED 74bff57d-c4d9-4f1a-8314-3e9927a53472 61 fields · synced Jun 20, 2026
- EUDAMED ee1af574-4957-470e-bcb6-a672dfef25a6 61 fields · synced Jul 9, 2026
- EUDAMED c894d856-bedc-4151-aced-bdf5c9b77f91 61 fields · synced Jul 11, 2026
- EUDAMED 3c1d286c-77c3-463b-8278-91bb4f2e8a34 61 fields · synced Jul 11, 2026
- EUDAMED b5482a96-737e-4ec6-a5be-59af1d067fc7 61 fields · synced Jul 14, 2026
- EUDAMED 33d8d8e7-cf77-4c15-b313-6128b0aacb7f 61 fields · synced Jul 17, 2026
- EUDAMED 637d5ed2-f9f9-4728-aa5c-9346c8d5db78 61 fields · synced Jul 20, 2026
- EUDAMED c411c512-6ae5-4c46-a071-b9df66adec9e 61 fields · synced Jul 21, 2026
- EUDAMED 094c21f5-11eb-4296-a1d5-df3299e6b912 61 fields · synced Jul 22, 2026
- EUDAMED 4ad7e3c1-12ae-4a32-a971-e2e298e89b6e 61 fields · synced Jul 25, 2026
- EUDAMED 2df891fb-2632-4110-9e3a-c1e25eef493b 61 fields · synced Jul 29, 2026
- EUDAMED 9b68f0d0-0299-426a-89d2-0987e7b33466 61 fields · synced Jul 30, 2026
- EUDAMED ee019e24-2eb3-45f9-915c-29d44fde77f1 61 fields · synced Aug 2, 2026