HomeChinaSHANDONG K.D.L. TECHNOLOGY CO.,LTD.

SHANDONG K.D.L. TECHNOLOGY CO.,LTD.

China · 德州 · www.kaidilan.com
✓ Record-verifiedregistrations found in 7 marketsUnified social credit code 91371428559913759G

This company holds 13 NMPA certificates in China and has registrations in United States, Brazil, Saudi Arabia, Canada, South Korea, Israel — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
13China registrations
Class I 10Class II 3
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
88listed device types
Class I 73Class II 15Class III 0
plus 107 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
25registered devices
Class I 13Class II 12
29 including historic records
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Manufacturing 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 Union29,251 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States107 registration records, 13 510(k), 0 PMA, 99 excluded
China13 certificates (Class III 0 / II 3 / I 10), as of 2026-09-04
United Kingdom0 confirmed, 19 excluded
Brazil25 confirmed, 59 excluded
Saudi Arabia2 confirmed, 25 excluded
Canada0 confirmed, 8 excluded
Manufacturer names merged into this page: SHANDONG CORECARE TECHNOLOGY LIMITED · SHANDONG RUYUE MEDICAL TECHNOLOGY CO.,LTD. · SHANDONG FENGAO MEDICAL TECHNOLOGY CO., LTD. · SHANDONG HUAMEI TECHNOLOGY CO.,LTD. · SHANDONG HENGCHANG MEDICAL TECHNOLOGY CO., LTD. · SHANDONG HUAMEI TECHNOLOGY CO., LTD.

Regulatory identity

Unified social credit code
91371428559913759G
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
18
Annual revenue
RMB 50–100M
Website
www.kaidilan.com
Product categories
注输、护理和防护器械医用耗材医用影像智慧健康口腔科器械医疗器械消毒灭菌器械

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
2010-08-04
Registered capital
CNY 20,000,000
Paid-in capital
CNY 20,000,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Textiles
Last approval date
2025-06-19
Recognitions
Micro and small enterpriseNational High-Tech 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

12017
12020
52021 · K210152
52022 · K222842
12024 · K232982

FDA listed device types

showing 8 of 88
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Detector And Alarm, Arrhythmia 1Gown, Surgical 1Catheter And Tip, Suction 1Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) 1Transmitters And Receivers, Electrocardiograph, Telephone 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Bed, Ac-Powered Adjustable Hospital 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20222140299医用防护口罩Class II
CN鲁械注准20212140750医用一次性防护服Class II
CN鲁械注准20212140145医用外科口罩Class II
CN鲁德械备20250011导光凝胶Class I
USK232982EMS Sculpt Machine2024-11-25
USK222842V-Patch Cardiac Monitor2022-10-20
USK221271Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)2022-07-27
BR82757189001SMART WALKERClass II
BR82757180002SMART CYCLEClass I
BR82757189003ZEPU-AI1 LIGHT - Sistema de avaliação e treinamento de marchaClass II
SAME0000001018SFDAA00013Anaaml Disposable Vinyl Gloves
SAME0000006406SFDAA00001Nursing Underpad

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