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
Phone
702 9874655 ext. 0

Products

Device Name Product Code
Powered Laser Surgical Instrument GEX
Monitor, Carbon-Dioxide, Cutaneous LKD
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia KLK
Flowmeter, Blood, Cardiovascular DPW
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia LPP
Probe, Blood-Flow, Extravascular DPT

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