FDA Registration
Active
🇲🇽 Mexico
ClimateLine 11
Reg #: 3021091708
·
FEI: 3021091708
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AP Services de Mexico, S. De R.L. De C.V.
- Registration Number
- 3021091708
- FEI Number
- 3021091708
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Blvd Insurgentes, No. 20545
- City
- Tijuana Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K203126
Owner / Operator
- Firm Name
- Plastiflex Healthcare Division of Plastiflex Group NV
- Operator Number
- 10031967
- Address
- Buntjesstraat 13
- City
- Paal Beringen
- State
- Limburg
- Postal Code
- B-3583
- Country
- BE
- Correspondent
- Patricia DuBois
US Agent
- Business Name
- Qserve Group US Inc.
- Contact Name
- Mindy McCann
- Address
- 350 S Main Street, Suite 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2024-12-06 |
Proprietary Names
ClimateLine 11
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)