FDA Registration Number: 3007006186

Last Validated: February 25, 2024

Status: Valid

Valid2024 U.S. FDA Medical Device Establishment Registration

PROCESS FOR PRF SARL

Establishment Information

49, rue Gioffredo
Nice Alpes-Maritimes, FR 06000

U.S. Agent and Official Correspondent

Registrar Corp
144 Research Drive
Hampton VA, USA 23666
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name Product Code Status Last Validated  
Elevator, Surgical, Dental EMJ Valid February 24, 2024

Device Listing

Device Name

Elevator, Surgical, Dental

Product Code

EMJ

Company Function(s)

Foreign Private Label Distributor, Specification Developer

Proprietary Name(s)

Soft Tissue Brush
Tray, Surgical, Instrument FSM Valid February 24, 2024

Device Listing

Device Name

Tray, Surgical, Instrument

Product Code

FSM

Company Function(s)

Specification Developer, Foreign Private Label Distributor

Proprietary Name(s)

TRAY A-PRF Mini Tray
ARMINITRAY 8*2*1
Mixer, Blood Tube GLE Valid February 24, 2024

Device Listing

Device Name

Mixer, Blood Tube

Product Code

GLE

Company Function(s)

Specification Developer, Foreign Private Label Distributor

Proprietary Name(s)

I-PRF+ Tubes 13 mL
S-PRF Tubes 10 mL
A-PRF Tubes 10mL
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC Valid February 24, 2024

Device Listing

Device Name

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code

JQC

Company Function(s)

Foreign Private Label Distributor, Specification Developer

Proprietary Name(s)

PRF Duo
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM Valid February 24, 2024

Device Listing

Device Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Product Code

GAM

Company Function(s)

Foreign Private Label Distributor, Specification Developer

Proprietary Name(s)

Monoglyc
Tourniquet, Nonpneumatic GAX Valid February 24, 2024

Device Listing

Device Name

Tourniquet, Nonpneumatic

Product Code

GAX

Company Function(s)

Foreign Private Label Distributor, Specification Developer

Proprietary Name(s)

A-PRF Tourniquet
PomCol
Spoon, Ear JZE Valid February 24, 2024

Device Listing

Device Name

Spoon, Ear

Product Code

JZE

Company Function(s)

Foreign Private Label Distributor, Specification Developer

Proprietary Name(s)

PAD
A-PRF Double Spoon
Scissors, Surgical Tissue, Dental EGN Valid February 24, 2024

Device Listing

Device Name

Scissors, Surgical Tissue, Dental

Product Code

EGN

Company Function(s)

Specification Developer, Foreign Private Label Distributor

Proprietary Name(s)

A-PRF Scissors
Instrument, Manual, Surgical, General Use MDM Valid February 24, 2024

Device Listing

Device Name

Instrument, Manual, Surgical, General Use

Product Code

MDM

Company Function(s)

Specification Developer, Foreign Private Label Distributor

Proprietary Name(s)

Tube holder POMPAC
Bowl
Bowl PomSwing
SMALL Compactor
INSTRUMENTS PRF
Big Compactor
Tube holder
Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate QBV Valid February 24, 2024

Device Listing

Device Name

Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

Product Code

QBV

Company Function(s)

Foreign Exporter, Foreign Private Label Distributor, Specification Developer

Proprietary Name(s)

PRF DUO
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG Valid February 24, 2024

Device Listing

Device Name

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code

LXG

Company Function(s)

Specification Developer, Foreign Private Label Distributor

Proprietary Name(s)

PRFBOXSTL PRF Box with silicon bed
PRF BOX
Forceps, General & Plastic Surgery GEN Valid February 24, 2024

Device Listing

Device Name

Forceps, General & Plastic Surgery

Product Code

GEN

Company Function(s)

Specification Developer, Foreign Private Label Distributor

Proprietary Name(s)

GIRAFE FORCEPS
FORCEPS

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