Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007817051

FEI Number

3007817051

Entity Name

Prodol Meditec Limited

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

1/F, 4/F, Block C, NO. 18, 7th Science Ave., Zhuhai Guangdong 519085, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRODOL MEDITEC S.A. (Owner Number: 9079460)

Owner / Operator Contact Address

Muelle T. Olavarri 5, getxo, ES-BI 48930, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121378

PMA Number

N/A

All Registered Proprietary Names

Airtraq Mobile APP Airtraq SP Demo Small (A-821) Airtraq SP Airtraq A-390 WiWi Camera (A-390) Airtraq Smartphone Adapter (A307) Airtraq A-390 Wifi Camera Full KIT (A-390-KIT) Airtraq SP Demo Double Lumen (A-871) Airtraq A-360 WiFi Camera (A-360) Airtraq SP Demo Adult Nasal (A-861) Airtraq SP Infant Nasal (A-051) Airtraq SP Pediatric (A-031) Airtraq SP Demo Infant Nasal (A-851) Airtraq Avant Demo Optics (A-581) Airtraq SP Small (A-021) Airtraq Avant Regular Blade (A-511) Airtraq SP Infant (A-041) Airtraq SP Regular (A-011) Airtraq SP Demo Pediatric (A-831) Airtraq SP Double Lumen (A-071) Airtraq Avant Docking station (A-590) Airtraq SP Adult Nasal (A-061) Airtraq Avant Optics (A-501) Airtraq CAM APP Airtraq SP Demo Regular (A-811) Airtraq Avant Small blade (A-521) Airtraq SP Demo Infant (A-841) Airtraq A-390 WiFi Camera Accessories (A-390-ACC) Airtraq Plus Video Laryngoscope Hyperangulated Blade H (A6HA) Airtraq Plus Video Laryngoscope Blade Channeled Regular Size 3 (A6C3) Airtraq Plus Video Laryngoscope Mac Blade Size 4 (A6M4) Airtraq Plus Video Laryngoscope Blade Channeled Infant Size 0 (A6C0) Airtraq Plus Video Laryngoscope Mac Blade Size 3 (A6M3) Airtraq Plus Video Laryngoscope Mac Blade Size 1 (A6M1) Airtraq Plus Video Laryngoscope Mac Blade Size 2 (A6M2) Airtraq Plus Video Laryngoscope (A600) Airtraq Plus Video Laryngoscope Blade Channeled Pediatric Size 1 (A6C1) Airtraq Plus Video Laryngoscope Blade Channeled Small Size 2 (A6C2)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2013-11-25

Official Correspondent

LUIS RUIZ

US Agent Details

Danny Daniel Email: Danny.Daniel@airtraq.com Phone: (972) 7682737

Related Public Records

Same Entity

PRODOL MEDITEC S.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005450700	PRODOL MEDITEC S.A.	LAS ARENAS Vizcaya, ES

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007817051. Last updated year: 2026. Please use registration number 3007817051 when referencing this establishment in official correspondence.