Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003924186

FEI Number

3003924186

Entity Name

AMBU Limited

City/State/Country

XIANG YU F.T.Z., XIAMEN Fujian, CN

Establishment Address

No.C,, Warehouse & Process Complex Building, XIANG YU F.T.Z., XIAMEN Fujian 361006, CN

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 King Mask Ambu Mini Perfit Ace Ambu Redi Ace Adult Ambu Perfit Ambu Perfit Ace Ambu Redi Ace Mini Ambu Reusable PEEP valve Ambu Spur II Ambu® SPUR® II Ambu® Mark IV Ambu Mark IV Resuscitator Mark IV HEAD WEDGE AMBU HEAD WEDGE AMBU DISPOSABLE HEAD IMMOBILIZER Airlife PEEP Valve Ambu PEEP 20 Valve Ambu PEEP Valve Ambu Disposable Face Mask Ambu Silicone Face Mask Ambu Disposable Pressure Manometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2005-03-28
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2005-03-28
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2015-09-18
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2017-01-13
OEV	Cardiopulmonary Resuscitation Aid Kit	Anesthesiology	Class 2	868.5915	2024-01-09
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2009-12-09
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2006-03-10
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2008-02-07
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2006-12-22
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2008-02-05

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
3022631687	Ambu Mexico Operations S.A. DE C.V.	Ciudad Juarez Chihuahua, MX
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
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003924186. Last updated year: 2026. Please use registration number 3003924186 when referencing this establishment in official correspondence.