HomeChinaShanghai Apolo Medical Technology CO.,ltd

Shanghai Apolo Medical Technology CO.,ltd

China · 上海 · www.apolomed.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000002904

This company holds 2 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
2China registrations
Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
26UDI-DI device records
Class IIa 1Class IIb 25
USUnited StatesFDA openFDA
5listed device types
Class I 0Class II 5Class III 0
plus 14 registration records and 15 510(k)
UKUnited KingdomMHRA PARD
8registered device records
Class IIa 1Class IIb 7
BRBrazilANVISA
0registered devices
2 including historic records
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
14active ARTG entries
Class I 1IIa 4IIb 9
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 Union26 raw hits, 0 excluded, 26 confirmed
United States14 registration records, 15 510(k), 0 PMA
China2 certificates (Class III 0 / II 2 / I 0), as of 2026-09-04
United Kingdom8 confirmed, 0 excluded
Manufacturer names merged into this page: SHANGHAI APOLO MEDICAL TECHNOLOGY CO.,LTD. · SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000002904
EU authorised representative
Lotus NL B.V.
UK responsible person
NPZ technology Ltd
Exhibition record
CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
75
Website
www.apolomed.com
Product categories
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
2001-10-30
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Instruments and meters manufacturing
Last approval date
2026-01-09
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseAbove-designated-size industrial 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

12011
32019
52020
22022
12024
12025
22026

FDA listed device types

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1Laser For Disruption Of Adipocyte Cells For Aesthetic Use 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
CN沪械注准20252090287超声治疗仪Class II
CN沪械注准20222090065红蓝光皮肤治疗仪Class II
EU06970745918196Diode Laser Therapy DevicesClass IIb
EU06970745918189Diode Laser Therapy DevicesClass IIb
EU06970745918172Diode Laser Therapy DevicesClass IIb
EU06970745918165Diode Laser Therapy DevicesClass IIb
UK58786Diode Laser Body Sculpture SystemsClass IIb
UK57890Fiber Laser Treatment SystemsClass IIb
UK47877Picosecond Nd:YAG Laser SystemsClass IIb
USK260256Q-Switched Nd: YAG Laser Systems2026-05-04
USK260017Picosecond Nd:YAG Laser Systems (Model: HS-298)2026-04-09
USK251031Fiber Laser Treatment Systems (HS-232,HS-233)2025-07-02

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