FDA Registration
Active
🇬🇧 United Kingdom
APATECH LTD.
Reg #: 3004450973
·
FEI: 3004450973
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- APATECH LTD.
- Registration Number
- 3004450973
- FEI Number
- 3004450973
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 360 CENTENNIAL AVENUE, CENTENNIAL PARK
- City
- ELSTREE Hertfordshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K102071
Owner / Operator
- Firm Name
- BAXTER HEALTHCARE CORPORATION
- Operator Number
- 1417572
- Address
- One Baxter Parkway
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Maha Nolasco
US Agent
- Business Name
- BAXTER HEALTHCARE CORPORATION
- Contact Name
- Maha Nolasco
- Address
- 25212 W. IL Route 120, RLT-04
- City
- Round Lake
- State
- IL
- ZIP
- 60073
- Country
- US
- [email protected]
- Phone
- 224 2706181
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wax, Bone | MTJ | Class U | Unknown | No | 2015-01-22 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2015-01-22 |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | Class 2 | Ear, Nose, Throat | No | 2015-01-22 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2015-01-22 |
Proprietary Names
Ostene
Actifuse
Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS
ALTAPORE
Altapore Shape
Actifuse Flow
Altapore MIS
Actifuse Shape
Actifuse ABX
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility