HomeUSAZenith Lab Inc

Zenith Lab Inc

USA · Pomona CA · zenithlabo.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000026595Unified social credit code 91320413720511570J

This company holds 1 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
1China registrations
Class I 1
as of 2026-09-04
EUEuropean UnionEUDAMED
74UDI-DI device records
IVD A 74
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
87registered device records
Custom-made 87
BRBrazilANVISA
9registered devices
Class I 7Class II 2
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 Union86 raw hits, 12 excluded, 74 confirmed
United States2 registration records, 0 510(k), 0 PMA, 10 excluded
China1 certificates (Class III 0 / II 0 / I 1), as of 2026-09-04
United Kingdom87 confirmed, 3 excluded
Brazil9 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Zenith Lab (Jiangsu) Co.,LTD · ZENITH LAB (JIANGSU) CO., LTD. · ZENITH LAB CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000026595
EU authorised representative
Umedwings Netherlands B.V.
Unified social credit code
91320413720511570J
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
USA
City
Pomona CA
Social-insurance enrolees
35
Annual revenue
RMB 10–30M
Website
zenithlabo.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsPoint-of-care & near-patient testing

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.

Business registration

Registration status
Active
Incorporated
2000-03-23
Registered capital
CNY 5,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Instruments and meters manufacturing
Last approval date
2024-01-16
Recognitions
Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA listed device types

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Centrifuge, Blood-Bank For In Vitro Diagnostic Use 1

Registration details (sample)

MarketIdentifierNameClass / date
CN苏常械备20151087号医用离心机Class I
EU06976374330002IVD A
EU06976374330019IVD A
EU06976374330057IVD A
EU06976374330804IVD A
UK38577Bar dental precision attachmentCustom-made
UK18083Bite Registration RimCustom-made
UK38584Bite registration rim wax, plateCustom-made
BR82796460011Família Centrifuga Microhematócrita SDMClass I
BR80153030151FAMÍLIA DE CENTRÍFUGAS MONTSERRATClass I
BR80889460044FAMÍLIA CENTRIFUGA VEICULAR MOBIL SAÚDEClass I

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