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Assure Medical Equipment Co.,Ltd

✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000042116Unified social credit code 913211123387856503

This company holds 6 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Australia, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥141, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

6China registrations

Class I 5Class II 1

as of 2026-09-04

EUEuropean UnionEUDAMED

≥141UDI-DI device records

Class I 141

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

19listed device types

Class I 18Class II 1Class III 0

plus 52 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

18registered device records

Class I 18

BRBrazilANVISA

3registered devices

Class I 3

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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 5

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 Union644 raw hits, 159 excluded, 141 confirmed. Large result set — only the first 300 verified

United States52 registration records, 7 510(k), 0 PMA, 6 excluded

China6 certificates (Class III 0 / II 1 / I 5), as of 2026-09-04

United Kingdom18 confirmed, 3 excluded

Brazil3 confirmed, 4 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD · JIANGSU ASSURE MEDICAL EQUIPMENT CO., LTD · JIANGSU ASSURE MEDICAL EQUIPMENT CO., LTD. · Zhenjiang Assure Medical Equipment Co., Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000042116
EU authorised representative: SUNGO Europe B.V.
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 913211123387856503
Exhibition record: Rehab & Elderly Care Expo (Spring 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2015-04-01
Registered capital: CNY 200,000,000
Paid-in capital: CNY 200,000,000
Legal form: Limited liability company (wholly owned by a non-natural-person corporation)
Industry classification: Electrical machinery and equipment
Last approval date: 2025-12-16
Recognitions: Micro and small enterpriseNational High-Tech Enterprise

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

12012 · K112816

42023 · K232230

12025 · K251159

12026 · K260319

FDA listed device types

showing 8 of 19

Attachment, Commode, Wheelchair 1Brake, Extension, Wheelchair 1Tips And Pads, Cane, Crutch And Walker 1Wheelchair, Mechanical 1Stand, Infusion 1Table, Mechanical 1Adaptor, Hygiene 1Footrest, Wheelchair 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	苏械注准20252192240	手动轮椅车	Class II
CN	苏镇械备20260068	手动轮椅车	Class I
CN	苏镇械备20260061	助行器	Class I
CN	苏镇械备20260060	医用拐	Class I
EU	06974231101536	—	Class I
EU	06974231101529	—	Class I
EU	06977479684960	—	Class I
EU	06977479680573	—	Class I
UK	57979	Heavy Duty Transport Chair	Class I
UK	41630	Transport Chair	Class I
UK	40539	Commode Chair	Class I
US	K260319	K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))	2026-03-31
US	K251159	Power wheelchair	2025-12-22
US	K232230	YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE)	2023-10-03
BR	82696710012	Cadeira Higiênica	Class I
BR	82696710017	Rollator	Class I
BR	82696710060	Cadeira de rodas manual	Class I
SA	ME0000004216SFDAA00022	Cerebral Palsy Chair	—

Assure Medical Equipment Co.,Ltd

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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