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Ranfac Corporation

USA · Avon

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

28listed device types

Class I 16Class II 12Class III 0

plus 35 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

9active device licences

Class I 1Class II 8

19 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

9active ARTG entries

IIa 9

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States35 registration records, 16 510(k), 0 PMA

Brazil8 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: Ranfac Corp. · RANFAC CORPORATION · RANFAC CORP

FDA 510(k) clearances by year

11985

11986

11993

11995

11996

12001

12003

12013

12014

22015

12017

22019

12020

12023

FDA listed device types

showing 8 of 28

Biopsy Needle 1System, Suction, Lipoplasty 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Instrument, Biopsy 1Pneumoperitoneum Needle 1Laparoscope, Gynecologic (And Accessories) 1Platelet And Plasma Separator For Bone Graft Handling 1Stimulator, Nerve 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223612	Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)	2023-02-21
US	K202287	Ran-Flex-B Bone Marrow Aspiration Needle	2020-09-18
US	K190177	J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,	2019-06-12
BR	82193589002	Kit Canula Marrow Cellution Biopsy	Class II
BR	82193589003	Kit Canula Marrow Cellution Aspiration	Class II
BR	82193589004	Separador de Plaquetas CERVOS	Class II
CA	5769	HARVARD MANOMETER SET	Class II
CA	5771	ARREGUI MULTIPURPOSE KNOT PUSHER LIGATOR	Class I
CA	5780	SATURING NEEDLE	Class II

Ranfac Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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