HomeChinaGeneral Meditech, Inc.

General Meditech, Inc.

China · 深圳 · www.genareal.com
✓ Record-verifiedregistrations found in 7 marketsUnified social credit code 91440300754296186P

This company holds 8 NMPA certificates in China and has registrations in United States, Brazil, Taiwan, Singapore, Australia, Russia — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
8China registrations
Class II 6Class III 2
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
3 including historic records
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
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2b 2
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 Union1,784 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States2 registration records, 2 510(k), 0 PMA, 87 excluded
China8 certificates (Class III 2 / II 6 / I 0), as of 2026-09-04
United Kingdom0 confirmed, 18 excluded
Brazil0 confirmed, 5 excluded
Saudi Arabia0 confirmed, 4 excluded
Canada0 confirmed, 8 excluded
Manufacturer names merged into this page: GENERAL MEDITECH, INC.

Regulatory identity

Unified social credit code
91440300754296186P
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
61
Annual revenue
RMB 100–500M
Website
www.genareal.com
Product categories
医用电子

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
2003-09-26
Registered capital
CNY 20,000,000
Paid-in capital
CNY 16,000,000
Legal form
Joint-stock limited company (unlisted)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2026-01-26
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseGazelle enterpriseAbove-designated-size industrial enterprise
Listing
Listed on the NEEQ

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 510(k) clearances by year

12009 · K082789
12010 · K092970

FDA listed device types

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) 1Oximeter 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20233070522脑电麻醉深度监测仪Class III
CN国械注准20173073044病人监护仪Class III
CN粤械注准20252071313无创血流动力学检测仪Class II
CN粤械注准20162211409中央监护系统软件Class II
USK092970GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H2010-02-02
USK082789G1B PULSE OXIMETER2009-01-07

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