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Samyang Biopharm Corporation

Korea, Republic · Seongnam-Sigyeonggi-do Seongnam-si Gyeon · www.samyangbiopharm.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN DE-MF-000007993

This company has registrations in European Union, United Kingdom, Brazil, Australia — 4 overseas markets. EU UDI-DI records ≥226, 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

≥226UDI-DI device records

Class III 217IVD A 2IVD B 2IVD C 3IVD general 2

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

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

69registered device records

Class III 3IVD A 9IVD B 23IVD C 5IVD general 29

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class III 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

European Union742 raw hits, 74 excluded, 226 confirmed. Large result set — only the first 300 verified

United States0 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom69 confirmed, 4 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SAMYANG BIOPHARM CORPORATION

Regulatory identity

EU manufacturer SRN: DE-MF-000007993
EU authorised representative: Samyang Biopharm Magyarország Kft.
UK responsible person: R-Biopharm Rhone Ltd

Business registration

KRX ticker code: 0120G0
Registration status: Active
Incorporated: 2025-11-24

Business registration data from KRX KIND, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04049095012396	—	IVD A
EU	04049095210099	—	IVD B
EU	08809366478056	MONOFIX PGCL	Class III
EU	04049095210549	—	IVD C
UK	49853	RIDASCREEN Adenovirus	IVD B
UK	49863	RIDA GENE Adenovirus	IVD general
UK	58945	RIDASCREEN Spec. IgG Foodscreen Customized Plate	IVD general

Samyang Biopharm Corporation

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

Registration details (sample)

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