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Tracheal Tube Introducer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PA210114Model Standard
Identity
- Trade Name
- Tracheal Tube Introducer EUDAMEDTracheal Tube Introducer (Bougie), Size 14FR, OD 4.7mm FDA UDI
- Generic Name
- Endotracheal tube introducer, single-use FDA UDI
- Device Name
- Tracheal Tube Introducer EUDAMED
- Model / Reference
- Standard EUDAMEDPA210114 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- PA210114 FDA UDI
- Primary DI / UDI-DI
- 06923310903165 EUDAMEDFDA UDI
- Basic UDI-DI
- 69233109PA21LW EUDAMED
- FDA Product Code
- BSR FDA UDI
- EMDN Code
- R018004 INTUBATION DEVICE GUIDES EUDAMED
- GMDN Term
- Endotracheal tube introducer, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5790 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
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Tracheal Tube Introducer by Hangzhou Formed Medical Devices Co., Ltd. — 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 | 69233109PA21LW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 311f5ee9-9f94-4bb4-950e-3b31922b4896 61 fields · synced Jul 12, 2026
- FDA UDI 2069a9a8-4503-4241-b7d0-e360e68963af 33 fields · synced May 30, 2026