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Tracheal Tube Introducer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PA210119Model StandardRef PA2103D15Model VentedRef PA210105Ref PA210212Ref PA2103F10ERef PA210208Ref PA210515Ref PA2107D12Ref PA210215-80Ref PA210115-100Ref PA210110-60Ref PA210215Ref PA2103D10Ref PA210215-60Ref PA210112Ref PA210210-80Ref PA210514Ref PA2107D19Ref PA2107D11Ref PA2107D14Ref PA210310Ref PA210110-100Ref PA210206Ref PA210311Ref PA210110Ref PA210310TDERef PA210315TDERef PA2103F14TDERef PA2103F14NRef PA2103F10NRef PA2103F10DRef PA210308TDE
Identity
- Trade Name
- Tracheal Tube Introducer EUDAMEDTracheal Tube Introducer (Bougie), Size 10FR, OD 3.3mm FDA UDI
- Generic Name
- Endotracheal tube introducer, single-use FDA UDI
- Device Name
- Tracheal Tube Introducer EUDAMED
- Model / Reference
- Standard EUDAMEDPA210119 EUDAMEDVented EUDAMEDPA2103D15 EUDAMEDPA210105 EUDAMEDPA210212 EUDAMEDPA2103F10E EUDAMEDPA210208 EUDAMEDPA210515 EUDAMEDPA2107D12 EUDAMEDPA210215-80 EUDAMEDPA210115-100 EUDAMEDPA210110-60 EUDAMEDPA210215 EUDAMEDPA2103D10 EUDAMEDPA210215-60 EUDAMEDPA210112 EUDAMEDPA210210-80 EUDAMEDPA210514 EUDAMEDPA2107D19 EUDAMEDPA2107D11 EUDAMEDPA2107D14 EUDAMEDPA210310 EUDAMEDPA210110-100 EUDAMEDPA210206 EUDAMEDPA210311 EUDAMEDPA210110 EUDAMEDFDA UDIPA210310TDE EUDAMEDPA210315TDE EUDAMEDPA2103F14TDE EUDAMEDPA2103F14N EUDAMEDPA2103F10N EUDAMEDPA2103F10D EUDAMEDPA210308TDE EUDAMED
Identifiers
- Catalog Number
- PA210110 FDA UDI
- Primary DI / UDI-DI
- 06923310904865 EUDAMED06923310907309 EUDAMED06923310906722 EUDAMED06923310906357 EUDAMED06923310909914 EUDAMED06923310903776 EUDAMED06923310903271 EUDAMED06923310906814 EUDAMED06923310910934 EUDAMED06923310910880 EUDAMED06923310910835 EUDAMED06923310903219 EUDAMED06923310907262 EUDAMED06923310910927 EUDAMED06923310906340 EUDAMED06923310910903 EUDAMED06923310907323 EUDAMED06923310906845 EUDAMED06923310906807 EUDAMED06923310906821 EUDAMED06923310903233 EUDAMED06923310910859 EUDAMED06923310903189 EUDAMED06923310906777 EUDAMED06923310903158 EUDAMEDFDA UDI06923310910125 EUDAMED06923310910149 EUDAMED06923310910132 EUDAMED06923310908450 EUDAMED06923310910538 EUDAMED06923310910545 EUDAMED06923310910118 EUDAMED
- Basic UDI-DI
- 69233109PA21LW EUDAMED69233109PA21038K 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 (33)
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- EUDAMED 9732f8dd-46dc-4f6a-9cec-5e90327be6c2 61 fields · synced May 17, 2026
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- EUDAMED 3aef721d-5105-44e0-b3f9-8cf543236c06 61 fields · synced May 18, 2026
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- EUDAMED 49e44455-7f3f-4dc4-bf49-ce1a643fcdda 61 fields · synced May 18, 2026
- EUDAMED 99250aaf-1f4a-4258-a963-017083d85d22 61 fields · synced May 18, 2026
- EUDAMED 53fd271a-a36f-4f2c-af84-72cba252320a 61 fields · synced May 18, 2026
- EUDAMED d3ccbad0-376f-4bad-aa25-231d473c3731 61 fields · synced May 19, 2026
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- FDA UDI 1de79636-c41e-4bde-9d13-de07bbc80c6b 33 fields · synced May 30, 2026
- EUDAMED 388375b5-f542-4b1d-a679-ff44aa5569f6 61 fields · synced Jun 14, 2026
- EUDAMED 0f6cb16d-bd89-496f-8c7e-1778e67a3290 61 fields · synced Jul 9, 2026
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- EUDAMED b05ab161-9fa8-433f-9f96-7d16f4c35e15 61 fields · synced Jul 30, 2026