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Monobind Inc.

USA · Lake Forest CA · monobind.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN US-MF-000021611

This company has registrations in European Union, United States, Brazil, Canada, South Korea, 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

54UDI-DI device records

IVD A 8IVD C 46

USUnited StatesFDA openFDA

65listed device types

Class I 20Class II 42Class III 1unclassified 2

plus 75 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

49registered devices

Class II 49

61 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

24 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Business type not stated 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

4active registrations

Class 1 4

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 Union54 raw hits, 0 excluded, 54 confirmed

United States75 registration records, 23 510(k), 0 PMA

Brazil49 confirmed, 0 excluded

Manufacturer names merged into this page: MONOBIND, INC. · MONOBIND INC. · MONOBIND INC · MONOBIND, INC

Regulatory identity

EU manufacturer SRN: US-MF-000021611
EU authorised representative: AR Experts B.V.

Business registration

Legal name: MONOBIND, INC.
LEI: 984500A992B52FD5CF45
Registration status: Active
Legal form: For-Profit Corporation General Stock (Corporation)
Incorporated: 1978-11-20
Registered address: 100 NORTH POINTE, LAKE FOREST, 92630
Registration authority: Business Entity Records, no. 903755
Registry record updated: 2022-09-13

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

FDA 510(k) clearances by year

31977

11978

21982

11983

11986

21992

11993

71997

11998

12002

12003

12008

12018

FDA listed device types

showing 8 of 65

Radioimmunoassay, Acth 1Radioimmunoassay (Two-Site Solid Phase), Ferritin 1System, Test, Rheumatoid Factor 1Biosensor, Immunoassay, Myoglobin 1System, Test, C-Reactive Protein 1System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer 1Radioimmunoassay, Thyroid-Stimulating Hormone 1Thyroglobulin, Antigen, Antiserum, Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00816870022222	CEA AccuLite CLIA Kit - 192 wells	IVD C
EU	00816870022215	CEA AccuLite CLIA Kit - 96 wells	IVD C
EU	00816870020563	CEA NEXT GEN AccuBind ELISA Kit - 192 wells	IVD C
EU	00816870020556	CEA NEXT GEN AccuBind ELISA Kit - 96 wells	IVD C
US	K181017	Free Testosterone AccuBind ELISA Test System	2018-07-20
US	K063437	ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300	2008-04-04
US	K030860	ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300	2003-08-22
BR	80048490069	FREE TRIIODOTHYRONINE (fT3)	Class II
BR	80048490070	ANTI-THYROGLOBULIN (ANTI-TG)	Class II
BR	80048490071	THYROGLOBULIN (TG)	Class II

Monobind Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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