Identity
- Trade Name
- DUTAU NOVATECH FDA UDI
- Generic Name
- Rigid optical bronchoscope FDA UDI
- Device Name
- DUTAU® NOVATECH® EUDAMEDBronchoscope Head FDA UDI
- Model / Reference
- 02BRD1100 EUDAMEDFDA UDI
- Description
- Bronchoscope Head FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14063108105186 EUDAMEDFDA UDI
- Basic UDI-DI
- 4063108DUTA4 EUDAMED
- Direct Marketing DI
- 14063108105186 EUDAMED
- 510(k) Number
- K242324 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- Z12020801 BRONCHOSCOPES EUDAMED
- GMDN Term
- Rigid optical bronchoscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dutau® Novatech® by Novatech Sa — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4063108DUTA4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Novatech Sa
- EUDAMED SRN
- FR-MF-000001658
Sources (2)
- EUDAMED 3ebff514-87f3-42ac-b2c7-8b5ac786961e 61 fields · synced Jun 18, 2026
- FDA UDI f4fa4666-90b6-4666-a625-790a3e693ff8 34 fields · synced May 30, 2026