Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022631687

FEI Number

3022631687

Entity Name

Ambu Mexico Operations S.A. DE C.V.

City/State/Country

Ciudad Juarez Chihuahua, MX

Establishment Address

Circuito Intermex Sur 4166, Colonia Parque Industrial Intermex, Ciudad Juarez Chihuahua 32575, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AMBU A/S (Owner Number: 8010067)

Owner / Operator Contact Address

13 BALTORPBAKKEN, --, BALLERUP, DK-NOTA DK-2750, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ambu® SPUR® II Ambu® Mark IV Ambu aScope 4 RhinoLaryngo Slim Ambu aScope 4 Broncho Slim Ambu aScope 4 Broncho Ambu aScope 4 Broncho Large Ambu aScope 4 Broncho Regular Ambu aView Monitor Ambu aScope 4 RhinoLaryngo Intervention Gas sampling line Circuit, Breathing (w connector, adaptor, y piece) Ambu Spur II Ambu aScope 4 Cysto Ambu King Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEV	Cardiopulmonary Resuscitation Aid Kit	Anesthesiology	Class 2	868.5915	2024-01-09
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2019-05-23
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-05-23
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2018-04-05
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-07-13
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2019-07-13
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2022-11-24
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2017-01-13
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2020-04-03
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2005-03-28

Official Correspondent

No official correspondent registered.

US Agent Details

Sanjay Parikh Business: Ambu Inc Email: SAP@ambu.com Phone: (410) 7686464

Related Public Records

Same Entity

AMBU A/S

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003924186	AMBU Limited	XIANG YU F.T.Z., XIAMEN Fujian, CN
9610691	Ambu A/S	Ballerup Hovedstaden, DK
3004040397	AMBU SDN.BHD.	PENANG Pulau Pinang, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24
Z-0035-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, 40 cm H2O Popoff elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83144-24
Z-0036-04	VIASYS Med Systems	1	Hyperinflation Circuit, consisting of a 2.0 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve and ported elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022631687. Last updated year: 2026. Please use registration number 3022631687 when referencing this establishment in official correspondence.