FDA Registration
Active
🇸🇪 Sweden
PERIMED AB
Reg #: 8030885
·
FEI: 3003244961
·
Expires 2026
Products
6
Proprietary Names
36
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- PERIMED AB
- Registration Number
- 8030885
- FEI Number
- 3003244961
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- DATAVAGEN 9 A
- City
- JARFALLA Stockholm
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K935495
Owner / Operator
- Firm Name
- PERIMED AB
- Operator Number
- 8030885
- Address
- DATAVAGEN 9 A
- City
- JARFALLA
- State
- Stockholm
- Postal Code
- SE-175 43
- Country
- SE
US Agent
- Business Name
- Perimed Inc
- Contact Name
- Samuel Pakvis
- Address
- 7485 W Azure Drive, Suite 126
- City
- Las Vegas
- State
- NV
- ZIP
- 89130
- Country
- US
- [email protected]
- Phone
- 702 9874655 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2007-12-29 |
| Monitor, Carbon-Dioxide, Cutaneous | LKD | Class 2 | Anesthesiology | No | 2007-12-29 |
| Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK | Class 2 | Anesthesiology | No | 2007-12-29 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2016-06-30 |
| Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | LPP | Class 2 | Anesthesiology | No | 2013-11-25 |
| Probe, Blood-Flow, Extravascular | DPT | Class 2 | Cardiovascular | No | 2012-08-23 |
Proprietary Names
PROBE 404
PROBE 404-NI
TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive (50 pcs) and TC 560 Contact Liquid
TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive
TC 560 Contact Liquid
PeriFlux 6000 Pressure System
PF 6050 Pressure Unit
PeriFlux 6000
PF 6051 Pressure Accessory Kit
PF 6001 Main Unit
PF 6054 Finger Pressure Kit
PF 6051-M Pressure Accessory Kit Metal Bayonet
PF 6052 Segmental Pressure 3 Cuff Method Kit
PF 6053 Segmental Pressure 4 Cuff Method Kit
PeriFlux 6000 Combined System
PF 6010 LDPM/Temp Unit
PF 6055 SPP Kit
PF 6840-1 TC Remote Panel 1 Channel
PeriFlux System 6000
PF 6001 Main Unit Complete
PeriFlux 6000 tcpO2 Stand-alone
PeriFlux 6000 tcpO2 System
PF 6840-2 TC Remote Panel 2 Channels
PF 6040 tcpO2/pCO2 Unit
PF 6840-4 TC Remote Panel 4 Channels
PeriCam PSI System
PeriCam PSI HR
PeriCam PSI NR
PeriCam PSI
PH 07-5 Small Tape-Fixated Probe Holder
PROBE 407
PSW ExM
PF 105-3 Double-Sided Tape Strips
PeriSoft for Windows Examination Manager
PH 07-4 Tape-Fixated Probe Holder
PROBE 457
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device