HomeKorea, RepublicH&Abyz Co., Ltd.

H&Abyz Co., Ltd.

Korea, Republic · Yongin-si · www.abyzr.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN KR-MF-000020684

This company has registrations in European Union, United States, United Kingdom — 3 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
4UDI-DI device records
Class IIa 2Class IIb 2
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 11 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 1Class IIb 1
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 Union4 raw hits, 0 excluded, 4 confirmed
United States11 registration records, 5 510(k), 0 PMA
United Kingdom2 confirmed, 0 excluded
Manufacturer names merged into this page: H&ABYZ

Regulatory identity

EU manufacturer SRN
KR-MF-000020684
EU authorised representative
Javitech Consulting GmbH
UK responsible person
MIS Healthcare Ltd

Company information

Country
Korea, Republic
City
Yongin-si
Website
www.abyzr.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsX-ray (analog, digital, mobile)

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12020 · K200018
22021 · K213497
12023 · K223930
12025 · K251223

FDA listed device types

System, X-Ray, Stationary 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08800070400043Class IIb
EU08800070400074Class IIb
EU08800070400005Class IIa
EU08800070400012Class IIa
UK61108Digital flat panel X-ray detectorClass IIa
UK37606Portable X-ray SystemClass IIb
USK251223HnX-P1, HnX-PB2025-08-04
USK223930A1417MCW/A1717MCW/F1417MCW2023-03-06
USK213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)2021-11-15

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