FDA Registration
Active
🇨🇳 China
AMBU Limited
Reg #: 3003924186
·
FEI: 3003924186
·
Expires 2026
Products
11
Proprietary Names
41
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- AMBU Limited
- Registration Number
- 3003924186
- FEI Number
- 3003924186
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.C,, Warehouse & Process Complex Building
- City
- XIANG YU F.T.Z., XIAMEN Fujian
- Country
- CN
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 protected]
- Phone
- 410 7686464 ext. 1136
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2005-03-28 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2005-03-28 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2015-09-18 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2017-01-13 |
| Cardiopulmonary Resuscitation Aid Kit | OEV | Class 2 | Anesthesiology | No | 2024-01-09 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2006-03-10 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2006-12-22 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2008-02-05 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2013-03-13 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2025-01-30 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2003-12-08 |
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
Ambu Mark IV Baby Resuscitator
Ambu® aBox 2
Ambu® SureSight® Blade Miller
Ambu® SureSight® Data Cable
Ambu® SureSight® Connect
Ambu® SureSight® Blade Hyperangulated Channeled
Ambu® SureSight® Mobile
Ambu® SureSight® Battery Charger
Ambu® aView 2 Advance
Ambu® SureSight® Blade Hyperangulated
Ambu® SureSight® Blade MAC
Gas sampling lines with filter
Gas sampling lines
AMBU LARYNGEAL MASK
Ambu AuraStraight
Ambu AuraFlex
Ambu Aura40
Ambu Aura-i
Ambu AuraGain
Ambu AuraOnce
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)