HomeChinaMEKICS Co., Ltd (烟台世宗医疗器械有限公司)

MEKICS Co., Ltd (烟台世宗医疗器械有限公司)

China · www.mek-ics.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN KR-MF-000012640Unified social credit code 91370600MA3C6QG416

This company has registrations in European Union, United States, Taiwan, Singapore, South Korea, Israel, Russia — 7 overseas markets. No China NMPA registrations were found.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
0China registrations
as of 2026-09-01
EUEuropean UnionEUDAMED
24UDI-DI device records
Class IIb 24
USUnited StatesFDA openFDA
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
6valid device licences
Class II 6
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Manufacturing 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 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 Union24 raw hits, 0 excluded, 24 confirmed
United States1 registration records, 1 510(k), 0 PMA
China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01
Manufacturer names merged into this page: MEKICS CO., LTD.

Regulatory identity

EU manufacturer SRN
KR-MF-000012640
EU authorised representative
Obelis s.a.
Unified social credit code
91370600MA3C6QG416
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
5
Annual revenue
RMB 10–30M
Website
www.mek-ics.com

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
2016-02-26
Registered capital
USD 4,000,000
Paid-in capital
USD 3,194,000
Legal form
Limited liability company (wholly owned by a foreign corporation)
Industry classification
Retail trade
Last approval date
2025-11-19
Recognitions
Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-03. 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

12025 · K242931

FDA listed device types

Sv70 Ventilator 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08809268914454HFT750Class IIb
EU08809268914317HFT750Class IIb
EU08809268914300HFT750Class IIb
EU08809268913990MV2000Class IIb
USK242931HFT750U2025-05-15

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