FDA Registration
Active
🇮🇱 Israel
PERFLEX LTD
Reg #: 3011532731
·
FEI: 3011532731
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- PERFLEX LTD
- Registration Number
- 3011532731
- FEI Number
- 3011532731
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4 Hamelacha str. New Ind. Area
- City
- Netanya Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K150454
Owner / Operator
- Firm Name
- Perflex Ltd
- Operator Number
- 10048177
- Address
- 4 Hamelacha str. New Ind. Area
- City
- Netanya
- State
- IL-NOTA
- Postal Code
- 4250539
- Country
- IL
- Correspondent
- Mrs. Perla Ben-Simon
US Agent
- Business Name
- Medes USA C/O Matan Arazy
- Contact Name
- Benzy Arazy
- Address
- 15201 6th Ave Ne
- City
- Shoreline
- State
- WA
- ZIP
- 98155
- Country
- US
- [email protected]
- Phone
- 415 9921126
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2015-12-20 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2014-12-14 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2015-06-01 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2015-06-01 |
Proprietary Names
Flexiclean
Thermofix , BDImpress
ACRYFREE BIOSENS FLEXINYLON
T-Crystal
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device