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PURGO BIOLOGICS INC.

Korea, Republic · Seongnam-Si

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Hong Kong, Israel, Russia — 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

4listed device types

Class I 0Class II 4Class III 0

plus 6 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

7 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

7 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1IIb 1

HKHong KongMDACS

3valid listings

Class II 2Class IV 1

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

5active registrations

Class 2b 1Class 3 4

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 States6 registration records, 6 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: PURGO BIOLOGICS INC. · PURGO BIOLOGICS INC.

FDA 510(k) clearances by year

12018 · K173188

12019 · K180992

12020 · K191737

22023 · K230091

12024 · K230305

FDA listed device types

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene 1Bone Grafting Material, Animal Source 1Barrier, Animal Source, Intraoral 1Barrier, Synthetic, Intraoral 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230305	THE Graft Collagen	2024-07-24
US	K230091	THE Cover	2023-10-06
US	K222549	OpenTex	2023-05-11
BR	80102512480	Sutura de PTFE Não Absorvível BIOTEX®	Class II
BR	80102512514	Membrana de PTFE Não Reabsorvível OpenTex®	Class II
BR	80102512515	Membrana de PTFE Não Reabsorvível OpenTex-TR	Class II

PURGO BIOLOGICS INC.

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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