Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016426842

FEI Number

3016426842

Entity Name

SHANDONG HAIDIKE MEDICAL PRODUCTS CO., LTD

City/State/Country

Heze Shandong, CN

Establishment Address

Tianfu Road, Dongcheng District, Shan County, Heze Shandong 274300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHANDONG HAIDIKE MEDICAL PRODUCTS Co., Ltd (Owner Number: 10061886)

Owner / Operator Contact Address

Tianfu Road, Dongcheng District, Shan County, Heze, CN-SD 274300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical Cap Sampling tube Isolation Gown Surgical Face Mask Sampling swab Medical cold compress walking aid Medical isolation mask Non Absorbable Surgical Nylon Suture Medical Goggle Skin Staple Remover Medical bed cover Non-absorbable Surgical Polyester Suture medical polymer splint polymer fixed bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-12
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2020-12-04
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-12
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-08-26
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-12-04
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2019-11-28
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2021-12-21
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-08-19
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2021-12-31
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-12
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2026-02-26
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-08-19
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-29
HSP	Splint, Traction	Orthopedic	Class 1	888.5890	2019-11-28
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-11-28

Official Correspondent

Lili Xu

US Agent Details

Sarah Galemmo Business: ICAS Biologics Co., Ltd. Email: US.agent@icas.org.cn Phone: (661) 8033155

Related Public Records

Same Entity

SHANDONG HAIDIKE MEDICAL PRODUCTS Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0034-2009	Surgical Specialties Corp	2	3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.

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3005090771	HUBEI WEIKANG PROTECTIVE PRODUCTS CO.LTD	XIANTAO Hubei, CN
2182303	Little Rapids Corporation	GREEN BAY, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016426842. Last updated year: 2026. Please use registration number 3016426842 when referencing this establishment in official correspondence.