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Hans Biomed Corporation

Korea, Republic · Daejeon

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Israel — 4 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

10listed device types

Class I 5Class II 5Class III 0

plus 13 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

0active device licences

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States13 registration records, 8 510(k), 0 PMA, 9 excluded

Brazil1 confirmed, 2 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: HANS BIOMED CORP. · HANS BIOMED S.A.

FDA 510(k) clearances by year

12012

12013

12014

22016

12018

12020

12023

FDA listed device types

showing 8 of 10

Suture, Surgical, Absorbable, Polydioxanone 1Filler, Bone Void, Calcium Compound 1Bone Grafting Material, Human Source 1Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) 1Suture, Absorbable, Synthetic, Polyglycolic Acid 1Cannula, Surgical, General & Plastic Surgery 1Guide, Needle, Surgical 1Stylet, Surgical, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220549	MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014	2023-03-07
US	K192423	MINT Product Family	2020-09-09
US	K171568	SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty	2018-02-22
BR	81696609001	Equipamento para Terapia Fotobiodinâmica Skymedic	Class II

Hans Biomed 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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