Identity
- Trade Name
- Airtraq SP Infant EUDAMEDAirtraq FDA UDI
- Generic Name
- Channelled video intubation laryngoscope FDA UDI
- Device Name
- Airtraq Video Laryngoscopes and accesories. EUDAMEDAirtraq SP Infant FDA UDI
- Model / Reference
- A-041 EUDAMEDFDA UDI
- Description
- Airtraq SP Infant FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436031030419 EUDAMEDFDA UDI
- Basic UDI-DI
- 843603103PRODOLMEDKT EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
- GMDN Term
- Channelled video intubation laryngoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5540 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Laryngoscope blade, reusable
Airtraq SP Infant by Prodol Medited Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 843603103PRODOLMEDKT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Prodol Medited Limited
- EUDAMED SRN
- CN-MF-000014746
- Authorised Representative
- Prodol Meditec S.A. ES-AR-000005064
Sources (2)
- EUDAMED d7f03f43-1963-4d7e-9b19-f4798ee7a3bc 61 fields · synced Jul 20, 2026
- FDA UDI 03878237-9666-4fcd-ad9f-e18d5792b542 33 fields · synced May 30, 2026