HomeChinaShandong Haidike Medical Products Co., Ltd.

Shandong Haidike Medical Products Co., Ltd.

China · 菏泽 · www.hdksuture.com、www.suturescn.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN CN-MF-000026113Unified social credit code 91371722059049941D

This company holds 86 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia — 5 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
86China registrations
Class I 64Class II 17Class III 4
as of 2026-09-04
EUEuropean UnionEUDAMED
81UDI-DI device records
Class I 9Class IIb 38Class III 34
USUnited StatesFDA openFDA
22listed device types
Class I 16Class II 5Class III 0unclassified 1
plus 22 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class IIb 1
BRBrazilANVISA
11registered devices
Class II 11
12 including historic records
SASaudi ArabiaSFDA
3registered 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.

European Union81 raw hits, 0 excluded, 81 confirmed
United States22 registration records, 5 510(k), 0 PMA
China86 certificates (Class III 4 / II 17 / I 64), as of 2026-09-04
United Kingdom1 confirmed, 0 excluded
Brazil11 confirmed, 0 excluded
Saudi Arabia3 confirmed, 0 excluded
Manufacturer names merged into this page: SHANDONG HAIDIKE MEDICAL PRODUCTS CO., LTD · SHANDONG HAIDIKE MEDICAL PRODUCTS CO.,LTD · Shandong Haidike Medical Products Co., Ltd · Shandong Haidike Medical Products Co.ltd

Regulatory identity

EU manufacturer SRN
CN-MF-000026113
EU authorised representative
CMC Medical Devices & Drugs SL
UK responsible person
Ivor Shaw Limited
Unified social credit code
91371722059049941D
Exhibition record
CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
China
Social-insurance enrolees
102
Annual revenue
RMB 100–500M
Website
www.hdksuture.com、www.suturescn.com
Product categories
手术器械植入器械注输、护理和防护器械中医器械

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
2012-12-27
Registered capital
CNY 3,200,000
Paid-in capital
CNY 3,200,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Pharmaceutical manufacturing
Last approval date
2025-11-06
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SMERecognised enterprise technology centre

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

22021 · K212603
22023 · K230746
12024 · K232355

FDA listed device types

showing 8 of 22
Cap, Surgical 1Accessory, Surgical Apparel 1Pack, Hot Or Cold, Disposable 1Staple, Removable (Skin) 1Tape And Bandage, Adhesive 1Non-Surgical Gown 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Container, Specimen Mailer And Storage, Non-Sterile 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263020495可吸收性外科缝线Class III
CN国械注准20243132201疝修补补片Class III
CN国械注准20233021204可吸收性外科缝线Class III
CN国械注准20233020195可吸收性外科缝线Class III
EU06926973959364VIDUClass III
EU06926973959357VIDUClass III
EU06926973959333VIDUClass III
EU06926973959326VIDUClass III
UK13910Silk surgical suture with needleClass IIb
USK232355Non absorbable Surgical Silk Suture2024-01-16
USK230746Non absorbable Surgical Polypropylene Suture2023-09-14
USK231183Non absorbable Surgical Polyester Suture2023-08-25
BR80722809003Fio de Sutura de Poliamida (Nylon) DBI MedClass II
BR80722809004Fio de Sutura de Polipropileno DBI MedClass II
BR80722809005Fio de Sutura de Poliester DBI MedClass II
SAME0000002241SFDAA00002Isolation Eye Cover
SAME0000002241SFDAA00001Isolation Gown

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