SPECLIPSE, INC.

Korea, Republic · Ansan-Si Gyeonggi

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Taiwan, Australia, Israel, Russia — 5 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

1listed device types

Class I 0Class II 1Class III 0

plus 3 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2IIa 2IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States3 registration records, 3 510(k), 0 PMA

Manufacturer names merged into this page: SPECLIPSE, INC.

Market	Identifier	Name	Class / date
US	K261214	PICO SHINING (PICO-K; PICOFY)	2026-05-11
US	K253342	PICO-K	2025-12-24
US	K253344	BELLUS-Q	2025-11-25

SPECLIPSE, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies