HomeChinaShandong Shangwei Medical Products Co., Ltd.

Shandong Shangwei Medical Products Co., Ltd.

China · 济宁 · www.sdswyl.com
✓ Record-verifiedregistrations found in 4 marketsUnified social credit code 91370881562529707L

This company holds 19 NMPA certificates in China and has registrations in United States, United Kingdom, Saudi Arabia — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
19China registrations
Class I 13Class II 6
as of 2026-09-04
EUEuropean UnionEUDAMED
0UDI-DI device records
USUnited StatesFDA openFDA
3listed device types
Class I 3Class II 0Class III 0
plus 3 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
8registered device records
Class I 8
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered 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
pendingnot queried
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.

United States3 registration records, 2 510(k), 0 PMA, 2 excluded
China19 certificates (Class III 0 / II 6 / I 13), as of 2026-09-04
United Kingdom8 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,LTD · Shandong Shangwei Medical Products Co.,Ltd · SHANDONG SHANGWEI MEDICAL PRODUCTS CO.,L TD.

Regulatory identity

UK responsible person
KINGSMEAD SERVICE LIMITED
Unified social credit code
91370881562529707L
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
22
Annual revenue
over RMB 500M
Website
www.sdswyl.com
Product categories
医用耗材

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
2010-09-28
Registered capital
CNY 10,200,000
Paid-in capital
CNY 7,965,000
Legal form
Joint-stock limited company (unlisted, natural-person invested or controlled)
Industry classification
Wholesale trade
Last approval date
2026-04-29
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMESRDI SME

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

22021 · K210779

FDA listed device types

Vinyl Patient Examination Glove 1Polymer Patient Examination Glove 1Accessory, Surgical Apparel 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20252150519电动液压手术台Class II
CN鲁械注准20252010212移动式LED手术无影灯Class II
CN鲁械注准20222151036电动病床Class II
CN鲁械注准20192150635电动手术台Class II
UK56286Disposable Nitrile Glove, Non-sterileClass I
UK56286Disposable Nitrile Glove, Non-sterileClass I
UK56286Disposable Nitrile Glove, Non-sterileClass I
USK210779Powder Free Nitrile Patient Examination Gloves, Blue Color2021-11-10
USK210780Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)2021-05-14
SAME0000004140SFDAA00044DISPOSABLE MEDICAL VINYL GLOVES
SAME0000005902SFDAA00001disposable vinyl gloves

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