FDA Registration
Active
🇲🇽 Mexico
Ambu Mexico Operations S.A. DE C.V.
Reg #: 3022631687
·
FEI: 3022631687
·
Expires 2026
Products
7
Proprietary Names
14
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Ambu Mexico Operations S.A. DE C.V.
- Registration Number
- 3022631687
- FEI Number
- 3022631687
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Circuito Intermex Sur 4166, Colonia Parque Industrial Intermex
- City
- Ciudad Juarez Chihuahua
- Country
- MX
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 |
|---|---|---|---|---|---|
| Cardiopulmonary Resuscitation Aid Kit | OEV | Class 2 | Anesthesiology | No | 2024-01-09 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2019-05-23 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2019-05-23 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2022-11-24 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2017-01-13 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2020-04-03 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2005-03-28 |
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
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)