HomeUSAHycor Biomedical , Ltd.

Hycor Biomedical , Ltd.

USA · Garden Grove
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel, Russia — 6 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 2Class II 2Class III 0
plus 14 registration records and 66 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 4Class II 1
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
45active device licences
Class II 45
47 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IVD Class 1 1IVD Class 2 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
5active registrations
Class 1 4Class 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 States14 registration records, 66 510(k), 0 PMA
Brazil5 confirmed, 0 excluded
Canada45 confirmed, 0 excluded
Manufacturer names merged into this page: HYCOR BIOMEDICAL · HYCOR BIOMEDICAL GMBH

Company information

Country
USA
City
Garden Grove

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

41989
51990
11991
71992
11993
21994
81995
91996
101997
22002
22003
12004
12005
22008
12018
12019
12020
12022
22025
52026

FDA listed device types

System, Test, Radioallergosorbent (Rast) Immunological 1System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Reagents, Specific, Analyte 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut2026-07-24
USK260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut2026-07-21
USK260280NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg2026-06-18
BR82775100002Família Sistema de Imunoensaio NOVEOS®Class II
BR82775100003Família NOVEOS Fluo BeadsClass I
BR82775100004Pacote de Concentrado de Tampão de LavagemClass I
CA28128AUTOSTAT II ANTI-JO-1 KITClass II
CA28129AUTOSTAT II ENA SCREENClass II
CA28130AUTOSTAT II ENA-6 PROFILEClass II

Similar companies

Abaxis
USA · markets 9
Accorto Regulatory Solutions LLC
USA · markets 0
Accumold LLC
USA · markets 1
AccuVein Inc.
USA · markets 8
Acme Monaco Corporation
USA · markets 4
ACON Laboratories, Inc.
USA · markets 9
Is this your company? Claim the page, add information or report a data error.Claim / report an error →