AMBU SDN.BHD.

FDA Device Registration & Listing · PENANG Pulau Pinang, MY · Registration 3004040397

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004040397
FEI Number
3004040397
Entity Name
AMBU SDN.BHD.
City/State/Country
PENANG Pulau Pinang, MY
Establishment Address
LOT 69-B, Lintang Bayan Lepas 6, Phase IV, PENANG Pulau Pinang 11900, MY
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Neuroline Cup Electrode Cup Electrode Neuroline aScope BronchoSampler 60 SC Neuroline 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® aBox™ 2 Ambu® aScope™ 5 Uretero (Reverse Deflection) Neuroline 715 Neuroline Ambu aScope Gastro Large Ambu aBox 2 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 Neuroline Ground Electrode Ambu aScope Gastro Ambu aBox2 Ambu aScope 4 RhinoLaryngo Slim Neuroline 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 aBox 2 Ambu® aScope™ 5 Cysto HD Ambu® aView™ 2 Advance Ambu aScope 4 Broncho Slim Ambu aScope 4 Broncho Ambu aScope 4 Broncho Large Ambu aScope 4 Broncho Regular Ambu aView Monitor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2009-12-09
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2019-01-10
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2009-12-09
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-10-22
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-10-22
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-06-02
FDT Duodenoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-04-18
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-04-18
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2005-03-28
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-06-25
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-06-25
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2007-12-27
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-04-08
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-04-08
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-01-17
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2020-04-03
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2009-12-09
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-02-09
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2022-02-09
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
IKT Electrode, Needle, Diagnostic Electromyograph Physical Medicine Class 2 890.1385 2009-12-09
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2021-06-17
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
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2022-07-25
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-10-22
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-10-22
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2016-08-19
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2018-04-05

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
3003924186 AMBU Limited XIANG YU F.T.Z., XIAMEN Fujian, CN
3022631687 Ambu Mexico Operations S.A. DE C.V. Ciudad Juarez Chihuahua, MX
9610691 Ambu A/S Ballerup Hovedstaden, DK

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

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

Similar Registrations

Registration Number Establishment Name Location
3015614098 CGX, LLC San Diego, CA, US
3015429360 SHAOXING YINGTUO HEALTHCARE CO.,LTD. Shaoxing Zhejiang, CN
3004695199 INCEREB LTD Dublin Dun Laoghaire-Rathdown, IE
3005581220 SPES MEDICA S.P.A BATTIPAGLIA Salerno, IT
9616086 DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. TIJUANA Baja California, MX
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004040397. Last updated year: 2026. Please use registration number 3004040397 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.