FDA Registration
Active
🇳🇱 Netherlands
BASKO HEALTHCARE B.V.
Reg #: 3003898328
·
FEI: 3003898328
·
Expires 2026
Products
9
Proprietary Names
15
Establishment Types
4
Classifications
9
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Registration Details
- Registration Name
- BASKO HEALTHCARE B.V.
- Registration Number
- 3003898328
- FEI Number
- 3003898328
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PIETER LIEFTINCKWEG 16
- City
- ZAANDAM Noord-Holland
- Country
- NL
Owner / Operator
- Firm Name
- BANDAGE-EN CORSETINDUSTRIE BASKO B.V.
- Operator Number
- 9053038
- Address
- Pieter Lieftinckweg 16
- City
- Zaandam
- State
- Noord-Holland
- Postal Code
- 1505HX
- Country
- NL
- Correspondent
- Amy - Eikelenboom
US Agent
- Business Name
- Fillauer LLC
- Contact Name
- A. Cole
- Address
- 2710 Amnicola Hwy
- City
- Chattanooga
- State
- TN
- ZIP
- 37406
- Country
- US
- [email protected]
- Phone
- 423 6240946 ext. 1
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Denis Brown | ITN | Class 1 | Physical Medicine | No | 2013-04-16 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2013-04-15 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2016-09-28 |
| Stirrup, External Brace Component | ITC | Class 1 | Physical Medicine | No | 2013-04-15 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2002-09-19 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2018-01-16 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2006-04-25 |
| Splint, Abduction, Congenital Hip Dislocation | IOZ | Class 1 | Physical Medicine | No | 2006-04-25 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2016-09-28 |
Proprietary Names
P.E.A.care splint
MultiStatic joints
MultiStatic Free Motion joints
MultiMotion Corrective System Joint
MultiMotion Free Movement Joint
CMCcare
MultiMotion System Bars
IQ Components Swing Phase Lock
Binky joints
IQ COMPONENTS SWIN
Stomacare
BASKO DISCOFLEX
Pavlik harness
Dynamic hip abduction orthosis for children
Clubycare
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device