Home›Korea, Republic›META BIOMED Co.,LTD

META BIOMED Co.,LTD

Korea, Republic · Cheongju-Sichungbuk · www.meta-biomed.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN KR-MF-000009681

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 10 overseas markets. EU UDI-DI records ≥5, the first 300 verified individually. 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

≥5UDI-DI device records

Class IIa 5

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

16listed device types

Class I 7Class II 9Class III 0

plus 30 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

14registered device records

Class IIa 12Class III 2

BRBrazilANVISA

7registered devices

Class I 1Class II 6

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

3active device licences

Class II 3

17 including historic records

TWTaiwanTFDA

11valid device licences

Class I 9Class II 2

SGSingaporeHSA SMDR

6device registrations

CLASS B 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

19active ARTG entries

Class I 1IIa 17IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

14active registrations

Class 2a 10Class 2b 1Class 3 3

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.

European Union7,844 raw hits, 95 excluded, 5 confirmed. Large result set — only the first 300 verified

United States30 registration records, 25 510(k), 0 PMA, 11 excluded

United Kingdom14 confirmed, 30 excluded

Brazil7 confirmed, 6 excluded

Canada3 confirmed, 4 excluded

Manufacturer names merged into this page: META BIOMED CO., LTD. · Meta Biomed, Inc. · META BIOMED VINA ONE MEMBER LIMITED LIABILITY COMPANY · META BIOMED CO. LTD. · META BIOMED CO,. LTD.

Regulatory identity

EU manufacturer SRN: KR-MF-000009681
EU authorised representative: Meta Biomed Europe GmbH
UK responsible person: Emergo Consulting (UK) Limited

FDA 510(k) clearances by year

22003

12004

12006

12007

32008

22013

22014

32018

32019

12020

22021

32023

12024

FDA listed device types

showing 8 of 16

Sealant, Pit And Fissure, And Conditioner 1Bone Grafting Material, Animal Source 1Cement, Dental 1Bone Grafting Material, Synthetic 1Material, Tooth Shade, Resin 1Material, Impression 1Crown And Bridge, Temporary, Resin 1Resin, Root Canal Filling 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08806387891932	Becht Paper Points	Class IIa
EU	08806387891925	Becht Paper Points	Class IIa
EU	08806387891918	Becht Paper Points	Class IIa
EU	08806387891901	Becht Paper Points	Class IIa
UK	62199	-Common Name: Dental Light Curing Cavity Liner -Brand Name: Biner LC	Class IIa
UK	35870	-Common name: Dental Composite Resin -Brand name: Ezfil	Class IIa
UK	66609	-Common Name: Resin Based Root Canal Sealer -Brand Name: ADSEAL	Class IIa
US	K242014	Jet Flow Bulk	2024-10-08
US	K232299	CeraPutty	2023-09-29
US	K230010	ADSEAL Plus	2023-04-13
BR	80801639005	Ponta de Papel Absorvente	Class II
BR	80801639006	Gutapercha	Class II
BR	80801630008	Ponta de papel absorvente AllPrime	Class I
CA	80571	E&Q MASTER SYSTEM (CORDLESS GUTTA PERCHA OBTURATOR)	Class II
CA	80572	SMARPEX FULL AUTOMATIC ELECTRONIC APEX LOCATOR	Class II
CA	94514	ELEMENTS OBTURATION SYSTEM	Class II