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Zhongshan First Medical Equipment Co., ltd.

✓ Record-verifiedregistrations found in 9 marketsEU SRN CN-MF-000044385Unified social credit code 914420005974750594

This company holds 9 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Russia — 8 overseas markets. EU UDI-DI records ≥1, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

9China registrations

Class I 7Class II 2

as of 2026-09-04

EUEuropean UnionEUDAMED

≥1UDI-DI device records

Class I 1

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

USUnited StatesFDA openFDA

21listed device types

Class I 16Class II 5Class III 0

plus 23 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class I 4

BRBrazilANVISA

14registered devices

Class I 14

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

8registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

6valid device licences

Class I 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 Union1,449 raw hits, 299 excluded, 1 confirmed. Large result set — only the first 300 verified

United States23 registration records, 4 510(k), 0 PMA, 53 excluded

China9 certificates (Class III 0 / II 2 / I 7), as of 2026-09-04

United Kingdom4 confirmed, 12 excluded

Brazil14 confirmed, 16 excluded

Saudi Arabia8 confirmed, 7 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. · ZHONGSHAN FIRST MEDICAL EQUIPMENT CO., LTD · ZHONGSHAN FIRST MEDICAL EQUIPMENT CO., LTD. · ZhongShan First Medical Equipment Co.,Ltd

Regulatory identity

EU manufacturer SRN: CN-MF-000044385
EU authorised representative: SUNGO Europe B.V.
UK responsible person: Wellkang Ltd
Unified social credit code: 914420005974750594
Exhibition record: Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2012-06-07
Registered capital: CNY 1,500,000
Paid-in capital: CNY 1,500,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2024-09-24
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

12007 · K071607

12008 · K071608

12012 · K121531

12026 · K253340

FDA listed device types

showing 8 of 21

Stretcher, Hand-Carried 1Cushion, Flotation 1Attachment, Commode, Wheelchair 1Tips And Pads, Cane, Crutch And Walker 1Orthosis, Lumbar 1Orthosis, Limb Brace 1Bedpan 1Adult Portable Bed Rails For Medical Purposes 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20182190935	电动轮椅车	Class II
CN	粤械注准20142190281	手动轮椅车	Class II
CN	粤中械备20260008	手动轮椅车	Class I
CN	粤中械备20230005	移位机	Class I
EU	06975845600972	—	Class I
UK	37961	Walker	Class I
UK	41069	Bath Chair	Class I
UK	31059	Potty Chair	Class I
US	K253340	Electric Wheelchair (AL-208S-063)	2026-04-03
US	K121531	A&J 5L POCA SERIES OXYGEN CONCENTRATOR	2012-07-17
US	K071608	A&J POCA01 OXYGEN CONCENTRATOR	2008-01-11
BR	80866380027	CADEIRA DE BANHO ZIMEDICAL	Class I
BR	80758210059	MULETAS	Class I
BR	80758210060	ANDADOR ARTICULADO	Class I
SA	ME0000013339SFDAA00001	Power wheelchair	—
SA	ME0000013339SFDAA00002	PCC 1610 Electric Wheelchair	—

Zhongshan First 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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