Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005450700

FEI Number

3005450700

Entity Name

PRODOL MEDITEC S.A.

City/State/Country

LAS ARENAS Vizcaya, ES

Establishment Address

MUELLE TOMAS OLAVARRI 5,3, LAS ARENAS Vizcaya 48930, ES

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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
3007817051	Prodol Meditec Limited	Zhuhai Guangdong, CN

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

Similar Registrations

Registration Number	Establishment Name	Location
3026201231	IntuBlade Co.	Lisle, IL, US
3019784580	AIMD INC.	Seoul, KR
3004530184	ANDERSEN CALEDONIA LTD	Bellshill Scotland, GB
1824226	KING SYSTEMS CORPORATION.	Noblesville, IN, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005450700. Last updated year: 2026. Please use registration number 3005450700 when referencing this establishment in official correspondence.