AMBU SDN.BHD.

Registration Details

Registration Name: AMBU SDN.BHD.
Registration Number: 3004040397
FEI Number: 3004040397
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: LOT 69-B, Lintang Bayan Lepas 6, Phase IV
City: PENANG Pulau Pinang
Country: MY

Owner / Operator

Firm Name: AMBU A/S
Operator Number: 8010067
Address: 13 BALTORPBAKKEN, --
City: BALLERUP
State: DK-NOTA
Postal Code: DK-2750
Country: DK

US Agent

Business Name: Ambu Inc
Contact Name: Sanjay Parikh
Address: 6721 Columbia Gateway Drive, Suite 200
City: Columbia
State: MD
ZIP: 21046
Country: US
Email: [email protected]
Phone: 410 7686464 ext. 1136

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Electrode, Cutaneous	GXY	Class 2	Neurology	No	2009-12-09
Container, Specimen, Sterile	FMH	Class 1	Pathology	No	2019-01-10
Cystoscope And Accessories, Flexible/Rigid	FAJ	Class 2	Gastroenterology, Urology	No	2024-10-22
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	Class 2	Gastroenterology, Urology	No	2024-10-22
Bronchoscope (Flexible Or Rigid)	EOQ	Class 2	Ear, Nose, Throat	No	2023-06-02
Duodenoscope And Accessories, Flexible/Rigid	FDT	Class 2	Gastroenterology, Urology	No	2024-04-18
Tape And Bandage, Adhesive	KGX	Class 1	General Hospital	No	2005-03-28
Ureteroscope And Accessories, Flexible/Rigid	FGB	Class 2	Gastroenterology, Urology	No	2024-06-25
Gastroscope And Accessories, Flexible/Rigid	FDS	Class 2	Gastroenterology, Urology	No	2024-04-08
Nasopharyngoscope (Flexible Or Rigid)	EOB	Class 2	Ear, Nose, Throat	No	2019-05-23
Electrode, Needle, Diagnostic Electromyograph	IKT	Class 2	Physical Medicine	No	2009-12-09
Electrode, Needle	GXZ	Class 2	Neurology	No	2007-12-27
Electrode, Electrocardiograph	DRX	Class 2	Cardiovascular	No	2013-05-06
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	CBI	Class 2	Anesthesiology	No	2021-05-21

Proprietary Names

Neuroline Cup Electrode Cup Electrode Neuroline aScope BronchoSampler 60 SC Neuroline 700 Neuroline 710 Ambu® aBox 2 Ambu® aScope 5 Cysto HD Ambu® aView 2 Advance Ambu® aScope 5 Broncho HD 5.6/2.8 Ambu® aScope 5 Broncho HD 5/2.2 Ambu aScope Duodeno 2 Ambu aBox 2 Skin Fix Ambu® aScope 5 Uretero (Standard Deflection) Ambu® aScope 5 Uretero (Reverse Deflection) Neuroline 715 Ambu aScope Gastro Large Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set Ambu aScope 5 Broncho HD 5/2.2 Sampler Set Ambu aScope 4 Cysto Ground Neuroline Ground Electrode Ground Electrode Ambu aScope Gastro Ambu aBox2 Ambu aScope 4 RhinoLaryngo Slim Concentric Needle Electrode Neuroline Concentric Needle Electrode Concentric aScope 4 Broncho Regular Sampler Set 5/2.2 aScope 4 Broncho Large Sampler Set 5.8/2.8 Ambu aScope 4 RhinoLaryngo Intervention Ambu aScope 5 Broncho HD 5.6/2.8 Ambu aScope 5 Broncho HD 5/2.2 Ambu aScope 4 Broncho Slim Ambu aScope 4 Broncho Ambu aScope 4 Broncho Large Ambu aScope 4 Broncho Regular Ambu aView Monitor Monopolar Neuroline Monopolar Needle Electrode Monopolar Needle Electrode Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set ECG Electrodes Ambu BlueSensor Ambu WhiteSensor Ambu® aScope 5 Broncho 4.2/2.2 Ambu® aScope 5 Broncho 2.7/1.2 Ambu VivaSight 2 DLT Neuroline Inoject Needle Electrode Inoject Inoject Needle Electrode Neuroline 720 Neuroline Twisted Pair Subdermal Needle Electrode Neuroline Subdermal Needle Electrode Twisted Pair Subdermal Needle Electrode Subdermal Needle Electrode

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)