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Ningbo Shenyu Medical Equipment CO.,Ltd.

✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000003330Unified social credit code 9133028107490095X9

This company holds 6 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia — 5 overseas markets. EU UDI-DI records ≥255, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

6China registrations

Class I 2Class II 3

as of 2026-09-04

EUEuropean UnionEUDAMED

≥255UDI-DI device records

Class I 255

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

USUnited StatesFDA openFDA

9listed device types

Class I 8Class II 1Class III 0

plus 11 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class I 4

BRBrazilANVISA

3registered devices

Class I 3

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

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

1active ARTG entries

Class I 1

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 Union412 raw hits, 45 excluded, 255 confirmed. Large result set — only the first 300 verified

United States11 registration records, 4 510(k), 0 PMA, 1 excluded

China6 certificates (Class III 0 / II 3 / I 2), as of 2026-09-04

United Kingdom4 confirmed, 0 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD. · NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000003330
EU authorised representative: SUNGO Europe B.V.
UK responsible person: SUNGO Certification Company Limited
Unified social credit code: 9133028107490095X9
Exhibition record: Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2013-07-26
Registered capital: CNY 1,080,000
Paid-in capital: CNY 1,080,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2022-01-17
Recognitions: Micro and small enterpriseNational High-Tech 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

12021 · K201461

12023 · K231110

12025 · K252517

12026 · K253599

FDA listed device types

showing 8 of 9

Wheelchair, Mechanical 1Table, Mechanical 1Adaptor, Hygiene 1Chair, Adjustable, Mechanical 1Cane, Safety Walk 1Walker, Mechanical 1Crutch 1Chair, With Casters 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	浙械注准20182560326	电动轮椅车	Class II
CN	浙械注准20182190326	电动轮椅车	Class II
CN	浙械注准20142190220	手动轮椅车	Class II
CN	浙甬械备20180132号	轮式助行架	Class I · 2018-08-22
EU	06950572845094	—	Class I
EU	06950572860370	—	Class I
EU	06950572850012	—	Class I
EU	06950572850333	—	Class I
UK	41069	Shower Chairs	Class I
UK	41875	Electric Wheelchair	Class I
UK	37951	Rollators	Class I
US	K253599	Electric Wheelchair (W-A807, W-A807L)	2026-02-17
US	K252517	Manual Wheelchair (SYIV100A008)	2025-10-03
US	K231110	Manual Wheelchair (A006)	2023-06-16
BR	80758210055	BANCO PARA BANHO	Class I
BR	80758210096	Andadores	Class I
BR	80758210097	Special Cares	Class I

Ningbo Shenyu 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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