FDA Registration
Active
🇭🇺 Hungary
CHRISOFIX HUNGARY KFT.
Reg #: 3031572052
·
FEI: 3031572052
·
Expires 2026
Products
5
Proprietary Names
58
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- CHRISOFIX HUNGARY KFT.
- Registration Number
- 3031572052
- FEI Number
- 3031572052
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Grassalkovich ut 272-274.
- City
- Budapest
- Country
- HU
Owner / Operator
- Firm Name
- Chrisofix Hungary Kft.
- Operator Number
- 10090905
- Address
- Grassalkovich ut 272-274.
- City
- Budapest
- State
- HU-BU
- Postal Code
- 1239
- Country
- HU
- Correspondent
- Judit Roza
US Agent
- Business Name
- Performance Health Supply
- Contact Name
- Melanie Leibowitz
- Address
- 3333 Finley Rd Ste 575
- City
- Downers Grove
- State
- IL
- ZIP
- 60515
- Country
- US
- [email protected]
- Phone
- 331 6889688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2024-05-30 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2024-05-30 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2024-05-30 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2024-05-30 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2024-05-30 |
Proprietary Names
Chrisofix rib splint
Chrisofix universal resting shell/orthosis for knee
Chrisofix universal resting shell/orthosis for foot & ankle - Open heel
Chrisofix universal resting shell/orthosis for foot & ankle
Chrisofix resting shell/orthosis for lower limb
Chrisofix scaphoid fracture orthosis (right)
Chrisofix 5th metacarpal fracture orthosis (right)
Chrisofix cubital, IV-line shell
Chrisofix universal wrist & thumb orthosis for emergency (right)
Chrisofix arterial infusion shell
Chrisofix thumb orthosis - Skier's thumb (left)
Chrisofix mallet finger splint (DIP)
Chrisofix extended scaphoid orthosis (right)
Chrisofix finger splint (DIP+PIP) - Malleable
Chrisofix carpal tunnel syndrome orthosis - Night use (right)
Chrisofix thumb orthosis (left)
Chrisofix infusion splint for adults
Chrisofix universal wrist & thumb orthosis for emergency (left)
Chrisofix universal resting shell/orthosis for hand & wrist
Chrisofix universal wrist orthosis (left)
Chrisofix 5th metacarpal fracture orthosis (left)
Chrisofix infusion splint for babies & small children
Chrisofix universal wrist orthosis (right)
Chrisofix De Quervain syndrome orthosis - Day use (right)
Chrisofix finger splint & mallet finger splint kit
Chrisofix thumb orthosis - Skier's thumb (right)
Chrisofix dorsal wrist orthosis
Chrisofix volar wrist orthosis
Chrisofix universal shell, orthosis and orth. for paresis and orth. for spasticity (hand & wrist & thumb) (left)
Chrisofix extended wrist orthosis for CTS (left)
Chrisofix saddle joint orthosis - Day use (left)
Chrisofix De Quervain syndrome orthosis - Night use (right)
Chrisofix universal working splint for wrist & carpal tunnel syndrome - Day use (left)
Chrisofix extended wrist orthosis for CTS (right)
Chrisofix universal working splint for wrist & carpal tunnel syndrome - Day use (right)
Chrisofix MP joint orthosis
Chrisofix universal shell, orthosis and orth. for paresis and orth. for spasticity (hand & wrist & thumb) (right)
Chrisofix universal elbow shell/orthosis 90°-110°
Chrisofix universal elbow shell 90°
Chrisofix carpal tunnel syndrome orthosis - Night use (left)
Chrisofix extensor pollicis longus orthosis (right)
Chrisofix saddle joint orthosis - Day use (right)
Chrisofix first aid wind-up splint
Chrisofix finger splint (DIP + PIP) - Fix
Chrisofix 5th metacarpal fracture & wrist orthosis (right)
Chrisofix extensor pollicis longus orthosis (left)
Chrisofix thumb orthosis (right)
Chrisofix splint for radial artery cannula
Chrisofix scaphoid fracture orthosis (left)
Chrisofix dialysis shell
Chrisofix universal elbow & wrist shell/orthosis 90°-110°
Chrisofix saddle joint orthosis - Night use (left)
Chrisofix saddle joint orthosis - Night use (right)
Chrisofix 5th metacarpal fracture & wrist orthosis (left)
Chrisofix extended scaphoid orthosis (left)
Chrisofix ulnar wrist orthosis
Chrisofix De Quervain syndrome orthosis - Day use (left)
Chrisofix De Quervain syndrome orthosis - Night use (left)
Establishment Types
Manufacture Medical Device