FDA Registration
Active
🇲🇽 Mexico
Additive Hinge Cap
Reg #: 9617594
·
FEI: 3003807466
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ICU MEDICAL DE MEXICO, S. de R.L. de C.V.
- Registration Number
- 9617594
- FEI Number
- 3003807466
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Avenida Cuarzo No. 250, Colonia Rancho Santa Clara, Maneadero
- City
- ENSENADA, Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K791796
Owner / Operator
- Firm Name
- ICU MEDICAL, INC.
- Operator Number
- 2025816
- Address
- 951 Calle Amanecer, --
- City
- San Clemente
- State
- CA
- Postal Code
- 92673
- Country
- US
- Correspondent
- Michelle Doherty
US Agent
- Business Name
- ICU MEDICAL, INC.
- Contact Name
- Michelle Doherty
- Address
- 951 Calle Amanecer
- City
- San Clemente
- State
- CA
- ZIP
- 92673
- Country
- US
- [email protected]
- Phone
- 949 3706562
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2017-03-23 |
Proprietary Names
Additive Hinge Cap
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device