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Shandong Haidike Medical Products Co., Ltd: FDA-registered device maker in Heze Shandong, China, 5 510(k) clearances

Name: Shandong Haidike Medical Products Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shandong Haidike Medical Products Co., Ltd is registered with the FDA (registration 3016426842) in Heze Shandong, China. It lists 22 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 16, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3016426842
Address: Tianfu Road, Dongcheng District, Shan County, Heze Shandong, China, 274300
Owner or operator: SHANDONG HAIDIKE MEDICAL PRODUCTS Co., Ltd (10061886)
Roles: Manufacturer
First device listed: November 28, 2019
Registered through: 2026
Brand names listed: Disposable Skin Stapler, Disposable medical face mask, Isolation Gown, Medical Cap, Medical Goggle, Medical Isolation Shoe Cover, Medical bed cover, Medical cold compress and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer	accessdata.fda.gov
Splint, Traction	HSP	1	Manufacturer	accessdata.fda.gov
Staple, Removable (Skin)	GDT	1	Manufacturer	accessdata.fda.gov
Stapler, Skin	QQS	1	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Silk	GAP	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyamide	GAR	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polypropylene	GAW	2	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov
Walker, Mechanical	ITJ	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 16, 2024	K232355	Non absorbable Surgical Silk Suture	GAP	Substantially Equivalent	Shandong Haidike Medical Product Co., Ltd.	accessdata.fda.gov
September 14, 2023	K230746	Non absorbable Surgical Polypropylene Suture	GAW	Substantially Equivalent	Shandong Haidike Medical Products Co., Ltd.	accessdata.fda.gov
August 25, 2023	K231183	Non absorbable Surgical Polyester Suture	GAT	Substantially Equivalent	Shandong Haidike Medical Products Co., Ltd.	accessdata.fda.gov
December 22, 2021	K212603	Non Absorbable Surgical Nylon Suture	GAR	Substantially Equivalent	Shandong Haidike Medical Product Co., Ltd.	accessdata.fda.gov
June 14, 2021	K210518	Surgical Face Mask	FXX	Substantially Equivalent	Shandong Haidike Medical Products Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.