Shandong Zhushi Pharmaceutical Group Co., Ltd.
Registered establishment in Heze, Shandong, China. 65 device types, 8 clearances.
Shandong Zhushi Pharmaceutical Group Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Hemostat, Pad, Eye and 63 other device types. Its earliest product listing with the FDA dates from 2016.
65device types registered with the FDA
8510(k) clearances
Registration
| Registered name | SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013496867 |
| FEI number | 3013496867 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 山东朱氏药业集团有限公司 |
|---|---|
| Unified social credit code | 9137172275746005XX |
| Source | NMPA UDI database |
Location
| City | Heze |
|---|---|
| Province | Shandong |
| Address | South Fanlou Road |
| Postal code | 274300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | BIB/dental bib | 2023 | 86 |
| Accessories, Implant, Dental, Endosseous | Class 1 | Blunt tip dispensing needle, scanbody, analog | 2023 | 70 |
| Accessories, Retractor, Dental | Class 1 | Mouth Prop | 2023 | 37 |
| Accessory, Surgical Apparel | Class 1 | Disposable Medical Face Mask, Protective Suit, Medical Isolation Mask | 2020 | 439 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Disposable Medical Laryngeal Mask | 2021 | 84 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | Disposable Sputum Suction Bag | 2021 | 58 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Swabs | 2021 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Single use sampler | 2021 | 100 |
| Bag, Reservoir | Class 1 | Medical Oxygen Bag | 2023 | 28 |
| Bandage, Cast | Class 1 | Fiberglass Casting Tape, Gypsum powder | 2018 | 81 |
| Cable, Electrode | Class 2 | ECG cable | 2023 | 47 |
| Cannula, Nasal, Oxygen | Class 1 | Disposable Nasal Oxygen Tube | 2021 | 97 |
| Cap, Surgical | Class 1 | Medical Cap | 2021 | 178 |
| Catheter, Drainage, Intraoral/Extraoral | Class 1 | Disposable Body Surface Drainage Tube | 2021 | 3 |
| Catheter, Ventricular, General & Plastic Surgery | Class 1 | Disposable Sterile Catheter | 2021 | 7 |
| Cleanser, Denture, Over The Counter | Class 1 | Mouthwash, Denture cleansing tablets, Cleanser, Denture, Denture Cleanser | 2023 | 34 |
| Compressor, Air, Portable | Class 2 | Medical compression atomizer | 2023 | 23 |
| Continuous Measurement Thermometer | Class 2 | Infrared Thermometer | 2021 | 115 |
| Cotton, Roll | Class 1 | Absorbent Cotton Balls, Disinfection Cotton Ball, Swab and Piece, prophy angle, cotton roll/Dental cotton roll | 2021 | 107 |
| Cup, Menstrual | Class 2 | Menstrual cup | 2019 | 20 |
| Dam, Rubber | Class 1 | Dental Dam;Dental Gum Dam;Gum Protector Gel ;Gingival Protection Gel | 2023 | 23 |
| Dispenser, Liquid Medication | Class 1 | Syringe Luer lock tip Cap | 2023 | 86 |
| Douche Apparatus, Vaginal, Therapeutic | Class 1 | Vaginal scrubber | 2019 | 20 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Liquid Dressing, Medical Sodium Hyaluronate Skin Repair Solution, Medical Sodium Hyaluronate Gel for Skin Repair,, Medical Sodium Hyaluronate Patch for Skin Repair, Wound nursing ointment, Medical skin repair liquid dressings | 2022 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | First-aid Bandage | 2023 | 195 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Scar Gel, Silicone Scar Patch | 2018 | 85 |
| Enteral Administration Kit (Adult & Pediatric) | Class 2 | Stomach Tube (Gastric Calibration Tube), Leving tube, Feeding tube, Enteral feeding bag | 2024 | 7 |
| Eraser, Dental Stain | Class 1 | Dione Cold Light Tooth WhiteningInstrument, Enamel Care/Colour Corrector/Hyaluronic Serum, Teeth Whitening Kit(Regular Strength Serum,Maximum Strength Serum,Desensitizing Serum,Teeth Whitening GEL> ,, Teeth Whitening Pen, Teeth Whitening Toothpaste, teeth whitening machine, Whitening Materials, | 2023 | 33 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Disposable Medical Face Mask | 2020 | 182 |
| Forceps, Tooth Extractor, Surgical | Class 1 | Dental Probe | 2023 | 20 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Disposable Medical Gauze / Sponge, Gauze Sponges, Non Woven Sponges, Non Woven Swabs, Abdominal Pads | 2023 | 266 |
| Gown, Surgical | Class 2 | Disposable Surgical Gown | 2021 | 68 |
| Hemostat | Class 1 | Medical Tweezers | 2021 | 12 |
| Insufflator, Vaginal | Class 1 | Vaginal Stuffing Adsorb Plug | 2021 | 1 |
| Irrigator, Sinus | Class 1 | Portable Oral Imigator Rechangeable, SINUS IRRIGATOR, Nasal WashBottle | 2023 | 27 |
| Mask, Oxygen | Class 1 | Disposable Oxygen Mask | 2021 | 126 |
| Mask, Scavenging | Class 1 | Face Mask | 2020 | 158 |
| Mask, Surgical | Class 2 | 3-Layer Medical Face Masks (XMM3L3C) / Disposable Surgical Face Mask (ZS-B),, 3-Layer Medical Face Masks with ties (XMM3HT)/Disposable Surgical Face Mask (ZS-S), Disposable Surgical Face Mask | 2021 | 125 |
| Massager, Therapeutic, Manual | Class 1 | Acupoint Therapy Patch / Detox Foot Patch / Foot Pad, Magnetic Therapy Patch | 2016 | 113 |
| Micro Pipette | Class 1 | Pipette | 2024 | 29 |
| Mirror, Mouth | Class 1 | Disposable Dental Instrument Kit | 2023 | 94 |
| Mouthpiece, Saliva Ejector | Class 1 | Mouthpiece, Saliva Ejector | 2023 | 68 |
| Needle, Dental | Class 1 | Dental anesthesia needle | 2023 | 56 |
| Needle, Hypodermic, Single Lumen | Class 2 | Disposable Sterile Syringe, Disposable Sterile Insulin Syringe, Disposable Sterile Injection Needles | 2022 | 71 |
| Non-Surgical Gown | Class 1 | Isolation Gown, Protective Suit | 2020 | 318 |
| Pack, Hot Or Cold, Disposable | Class 1 | Cooling Gel Patch, Heat pads, Cold Compress Gel, Heat pads, Far-infrared Physiotherapy Patch/Magnetic heat Patch/Ironing Therapy Patch/Disposable Infusion Hot Compress Patch, Heat Patch / Hyperthermia Patch/Gynecological Heat Patch/Steam Eye Mask, Sandwiched Moxibustion/Cauterize Hot Patch/Photoconductive Gel/Photon Cold Gel, Medical Ice Pad/Medical Ice Cap/Medical Antipyretic Patch/Medical Antipyretic Gel | 2016 | 176 |
| Pack, Hot Or Cold, Reusable | Class 1 | Pain relief cream, Pain relief patch | 2019 | 178 |
| Pad, Eye | Class 1 | Hydrogel Under Eye Patch | 2021 | 100 |
| Polymer Patient Examination Glove | Class 1 | Disposable Nitrile Examination Gloves | 2021 | 83 |
| Probe, Periodontic | Class 1 | PROBE, PERIODONTIC, Mouth Mirror | 2023 | 34 |
| Retainer, Surgical | Class 1 | Retainer Box, Denture box | 2023 | 10 |
| Shoe And Shoe Cover, Conductive | Class 1 | Medical Isolation Shoe Cover | 2021 | 32 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class 2 | Blood Collection Needle | 2020 | 36 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | Class 1 | medical polymer splint | 2018 | 62 |
| Suit, Surgical | Class 1 | Disposable Medical Face Mask | 2020 | 74 |
| Support, Breathing Tube | Class 1 | Breathing Tube, Endotracheal Tube Holder, Endotracheal Tube Support Clip, Breathing Tube Supports,, Single Patient Breathing Tube | 2024 | 14 |
| Syringe, Irrigating (Non Dental) | Class 1 | Disposable Sterile Irrigator | 2021 | 110 |
| Syringe, Piston | Class 2 | Disposable Sterile Syringe, Disposable Sterile Insulin Syringe, Disposable Sterile Injection Needles | 2022 | 60 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | Class 1 | Drainage Bags | 2021 | 13 |
| Tape And Bandage, Adhesive | Class 1 | Self-Adhesive Bandage / Elastic Bandage / Medical Breathable Tape | 2023 | 353 |
| Thermometer Kit | Class 2 | Theometer | 2020 | 11 |
| Tray, Impression, Preformed | Class 1 | Thermoplastic Mouth Tray, Mouth Piece/Dental mouthpiece,Teeth whitening tray; TRAY, IMPRESSION, PREFORMED | 2023 | 73 |
| Unit, Oral Irrigation | Class 1 | Oral irrigation unit/Dental Oral Irrigator, Water Flosser, DentalFlosser, Dental Water Jet,, Cordless Oral Irigator/Cordless DentalFlosser, Teether, Nozzle Tips for Water Flosser | 2023 | 128 |
| Unit, Syringe, Air And/Or Water | Class 1 | Unit, Syringe, AIR Andior Water | 2023 | 56 |
| Vinyl Patient Examination Glove | Class 1 | Disposable Vinyl Examination Gloves | 2021 | 72 |
Clearances
8 clearances name Shandong Zhushi Pharmaceutical Group Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232475 | 2024-05-10 | FPA | Traditional | This company |
| K212033 | 2022-08-17 | FMF | Traditional | This company |
| K210510 | 2021-08-12 | FYA | Traditional | This company |
| K210643 | 2021-08-04 | FXX | Traditional | This company |
| K210409 | 2021-07-28 | FXX | Traditional | This company |
| K203454 | 2021-04-29 | FLL | Traditional | This company |
| K203436 | 2021-04-28 | LZA | Traditional | This company |
| K203439 | 2021-02-26 | LYZ | Traditional | This company |
| K210772 | 2021-09-22 | FXX | Traditional | Vr Vertical, LLC Dba Xrgo |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shandong Haidike Medical Products Co., Ltd. | 22 |
| Coda Resources Ltd., Heze China | 9 |
| Shandong Caremed Medical Products Co., Ltd. | 6 |
| Biobase Medfuture Scientific Equipment Co., Ltd. | 5 |
| Shandong Shangwei Medical Products Co., Ltd. | 3 |
| Shandong Jieshi Medical Products Co., Ltd. | 2 |
| Shandong Xiaokang Biotechnology Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.