HomeChinaKERNEL MEDICAL EQUIPMENT CO.,LTD

KERNEL MEDICAL EQUIPMENT CO.,LTD

China · 徐州 · www.kernelmed.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000020694Unified social credit code 91320301608015657C

This company holds 26 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Singapore, Australia, Israel, Russia — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
26China registrations
Class I 2Class II 23Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
16UDI-DI device records
Class I 2Class IIa 14
USUnited StatesFDA openFDA
7listed device types
Class I 1Class II 6Class III 0
plus 13 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class I 1
BRBrazilANVISA
2registered devices
Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
10active ARTG entries
Class I 1IIa 9
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
5active registrations
Class 2a 3Class 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 Union16 raw hits, 0 excluded, 16 confirmed
United States13 registration records, 9 510(k), 0 PMA
China26 certificates (Class III 1 / II 23 / I 2), as of 2026-09-04
United Kingdom1 confirmed, 0 excluded
Brazil2 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD · XUZHOU KERNEL MEDICAL EQUIPMENT CO., LTD. · Xzhou Kernel MEDICAL EQUIPMENT CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000020694
EU authorised representative
Caretechion GmbH
UK responsible person
DP Medical Systems Limited
Unified social credit code
91320301608015657C
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
190
Annual revenue
RMB 100–500M
Website
www.kernelmed.com
Product categories
医用成像器械物理治疗器械妇产科、辅助生殖和避孕器械放射治疗器械眼科器械

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
1997-03-10
Registered capital
CNY 30,000,000
Paid-in capital
CNY 4,943,100
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Instruments and meters manufacturing
Last approval date
2025-08-27
Recognitions
Micro and small enterpriseNational High-Tech EnterprisePrivate technology enterpriseRecognised enterprise technology centre

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

12014
12016
22019
22020
12023
12025
12026

FDA listed device types

Light, Ultraviolet, Dermatological 1Lamp, Infrared, Therapeutic Heating 1Over-The-Counter Powered Light Based Laser For Acne 1Powered Laser Surgical Instrument 1Colposcope (And Colpomicroscope) 1Laser, Comb, Hair 1Light, Wood'S, Fluorescence 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20253051973X射线放射治疗系统Class III
CN苏械注准20252161379回弹式眼压计Class II
CN苏械注准20252091694紫外线光疗仪Class II
CN苏械注准20252091477盆底肌治疗仪Class II
EU06928798620733Photodynamic Therapy DeviceClass IIa
EU06928798620528308nm Excimer Phototherapy DeviceClass IIa
EU06928798620283UV PhototherapyClass IIa
EU06928798620276UV PhototherapyClass IIa
UK64925Colposcope SystemClass I
USK261775Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)2026-07-21
USK242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)2025-02-06
USK222751LED Light Therapy Device, KN-7000L2023-02-01
BR81136179006Capacete para crescimento de cabeloClass II
BR83044609004VITILUXClass II
SAME0000007528SFDAA00002Kernel

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