HomeChinaShandong Shinemed Technology Co., Ltd.

Shandong Shinemed Technology Co., Ltd.

China · Zibo · www.sdshinemed.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000038353Unified social credit code 91370303MA3N17AM1R

This company holds 4 NMPA certificates in China and has registrations in European Union, United States, Brazil, Australia — 4 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class I 2Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
14UDI-DI device records
Class I 14
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class II 1
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
2active ARTG entries
Class Is (sterile) 2
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 Union14 raw hits, 0 excluded, 14 confirmed
United States2 registration records, 0 510(k), 0 PMA, 1 excluded
China4 certificates (Class III 0 / II 2 / I 2), as of 2026-09-04
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: SHANDONG SHINEMED TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000038353
EU authorised representative
MedPath GmbH
Unified social credit code
91370303MA3N17AM1R
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
City
Zibo
Social-insurance enrolees
48
Annual revenue
RMB 50–100M
Website
www.sdshinemed.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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
2018-04-24
Registered capital
CNY 5,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2023-10-16
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SME

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 listed device types

Device, Intravascular Catheter Securement 1Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN鲁械注准20262140036一次性医用无菌手术膜Class II
CN鲁械注准20232140770医用无菌敷贴Class II
CN鲁淄械备20240085透气创口贴Class I
CN鲁淄械备20180092号透气胶带Class I
EU16976077620575Transparent film dressingClass I
EU16976077620568Transparent film dressingClass I
EU16976077620551Transparent film dressingClass I
EU16976077620544Transparent film dressingClass I
BR80567519005Curativo transparenteClass II

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