FDA Registration
Active
🇮🇱 Israel
PHARMASEPT LTD. MEDICAL PRODUCTS
Reg #: 3003623887
·
FEI: 3003623887
·
Expires 2026
Products
5
Proprietary Names
61
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- PHARMASEPT LTD. MEDICAL PRODUCTS
- Registration Number
- 3003623887
- FEI Number
- 3003623887
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9 Shaham St., Northern Industrial Park
- City
- Caesarea Central
- Country
- IL
Owner / Operator
- Firm Name
- PHARMASEPT LTD. MEDICAL PRODUCTS
- Operator Number
- 9045710
- Address
- 9 Shaham St., Northern Industrial Park
- City
- Caesarea
- State
- IL-NOTA
- Postal Code
- 3088900
- Country
- IL
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2023-06-21 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 2001-04-20 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2016-11-30 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2001-04-20 |
| Mountable Electromechanical Surgical System For Transluminal Approaches | QNM | Class 2 | General, Plastic Surgery | No | 2025-12-23 |
Proprietary Names
S11103 Pajunk Labeled Safersonic Conti with Gel
S11101 Pajunk Labeled Safersonic Single with Gel
DAN-33512NWG Safersonic Conti Narrow with Gel
DAN-33803WG Safersonic Single with Gel
DAN-33805WG Safersonic Medium with Gel
DAN-33825WG to Safersonic Long with Gel
DAN-33505NWG Safersonic Medium Narrow with Gel
DAN-33812WG to Safersonic Conti with Gel
PSC Florida
VMD90-4518 MS DRAPE For Zeiss W/HLT ANGLE LENS 45x118, 115x300cm
MU8090HR Microscope Cover MITAKA 120/390 HLT
VMD80-4518 Microscope Cover LEICA 115/300, 7 HLT
VMD80-5449 Leica Microscope Cover W/Angle Lens 54 x 149 (137cm X 380cm)
MU8090HRSN Microscope Cover MITAKA mm80, mm90, 80/266
Protective Cover 115*300 product code 80-412
HSD01 Protective Cover, HAWKSIGHT DRAPE
MU5153 Mitaka MM51 cover
VMD90-5449 Microscope Cover ZEISS 137/380 6.50 HLT
MU8190HRSN Microscope Cover MITAKA mm80, mm90, 80/276
MU8090HRW Microscope Cover MITAKA 137/380 HLT
S11103 Pajunk Labeled Safersonic Single
S11104 Pajunk Labeled Safersonic Conti
DAN-33805U Safersonic Medium Non Sterile
DAN-33803U Safersonic Single Non Sterile
DAN-33812U Safersonic Conti Non Sterile
DAN-33825 Safersonic Long
DAN-33803 Safersonic Single
DAN-33805 Safersonic Medium
DAN-33825U Safersonic Long Non Sterile
DAN-33812 Safersonic Conti
DAN-33803NT Safersonic Single - No Tape
4565 C-Arm Cover 152/265
4600 Mini C-Arm Cover & X-Ray Drape 105/220
88-300 C-Arm Cover Philips Veradius Unity 3 pieces
4625 Mini C-Arm Cover & X-Ray Drape 138/160
4444-HP C-Arm Cover UNIVERSAL 112/183
8070 Universal Handle Cover
4444 C-Arm Cover UNIVERSAL 112/183
5028 Protective Cover 80/100cm
5021 Protective Cover 100/100cm
88-742 C-ARM Kit
5004 Image Cover 65R
4445 C-Arm Cover IMAGE INTENSHFIER 115/240
5024 Protective Cover 75/75cm
5052A Protective Cover 95/75cm with Adhesive
BUY0549 Protective Cover- Scout Arm
5113 VIDEO - Laser Camera Cover 22*243
88-741 C-ARM
5006 Image Cover 45R
BUY0887 Protective Cover- Cart
5054 Protective Cover 90/90cm
4130 C-Arm Cover Siemens "SIREMOBIL 2000" 3 pieces
5110 Video Camera Cover 15/250cm
5026 Protective Cover 75/90cm
5120 X-Ray Cassette Cover
5002 Image Cover 36R
BUY0548 Protective Cover- Arm
88-740 Mini C-ARM 137/213
BUY0546 Protective Cover- Screen
FP-04-0020
Protective Cover, Multiport Unified Drape
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device