Zhejiang Gongdong Medical Technology Co., Ltd.
Manufacturer and brand owner in Taizhou, Zhejiang, China. 40 device types, 7 products catalogued, 3 clearances.
Zhejiang Gongdong Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Forceps, Otoscope and 38 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2006.
40device types registered with the FDA
7products catalogued under its own name
3510(k) clearances
Registration
| Registered name | Zhejiang Gongdong Medical Technology Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005739529 |
| FEI number | 3005739529 |
| DUNS | 529309049 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 浙江拱东医疗器械股份有限公司 |
|---|---|
| Unified social credit code | 91331003148185689U |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Taizhou |
|---|---|
| Province | Zhejiang |
| Address | a)No 10 & 39 ,Beiyuan Ave. |
| Postal code | 318020 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Disposable Face shield | 2020 | 439 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | PPLICATOR, ABSORBENT TIPPED non-sterile, sampling swab kit Non-Sterile | 2020 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Absorbent tipped applicator; Sampling Swab, APPLICATOR, ABSORBENT TIPPED sterile, sampling swab kit Sterile, | 2020 | 100 |
| Basin, Emesis | Class 1 | Placenta basin | 2026 | 65 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | Class 2 | Sterile Blood Culture Diversion Tube, No Activator | 2023 | 1 |
| Bottle, Collection, Vacuum | Class 2 | Semi Rigid Suction Canister System | 2023 | 88 |
| Bottle, Roller, Tissue Culture | Class 1 | 2007 | 7 | |
| Cassettes, Tissue | Class 1 | Biopsy foam pads;embedding rings;storage drawer;tissue capsules | 2016 | 16 |
| Container, Sharps | Class 2 | Sharp Container,Needle collector, GDC-03-F, GDC-03-X, GDC-05-F, GDC-05-X, GDC-07-F, GDC-07-X, GDC-13-X,SC-01Q, SC-02Q, SC-05Q, SC-01G, SC-02G, SC-06 | 2008 | 18 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | Container, Specimen Mailer AND Storage, NON-Sterile | 2020 | 51 |
| Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | Class 1 | Synergy Beaker;, Gongdong Vial Collection Containers; Gongdong Vial DOA Kits; Gongdong Vial Transport Containers; | 2022 | 4 |
| Container, Specimen, Non-Sterile | Class 1 | Gongdong Centrifugation Tube, Sample Cup& Specimen container, Test tube, Vacumm Urine tube, Biohazard Bags, Saliva Collection Kit,NON Sterile and 5 more | 2007 | 115 |
| Container, Specimen, Sterile | Class 1 | Cryogenic Vial, Plastic Round Bottom Tube with Preservative for Urinalysis; FLUID COLLECTION BAG, Sterile Urine Specimen Containers with Temperature Strip; Sterile Urine Specimen Containers;, Vacuum specimen collection tube NO ADDIT; Plastic Conical Bottom Tube with Preservative for Urinalysis;, Saliva Collection Kit, Sterile Urine Specimen Containers w/ needle cap and 5 more | 2006 | 79 |
| Culture Media, Non-Propagating Transport | Class 1 | Disposable Urine Collection Tube, 4ml,7ml,8ml,10ml round or conical bottom with Boric acid Additve | 2024 | 11 |
| Culture Media, Non-Selective And Non-Differential | Class 1 | Viral Transport Media Kit | 2020 | 18 |
| Curette, Ear | Class 1 | Multiple &Accessories | 2011 | 9 |
| Cuvette, Thermostated | Class 1 | Gongdong Cuvette | 2007 | 4 |
| Depressor, Tongue, Non-Surgical | Class 1 | Tongue Depressor | 2007 | 100 |
| Device, Specimen Collection | Class 1 | Disposable Urine Collection Tube, 4ml,7ml,8ml,10ml round or conical bottom with Boric acid Additve | 2024 | 3 |
| Dish, Tissue Culture | Class 1 | Gongdong Petri dish, Plastic Culture Dishes | 2007 | 30 |
| Dispenser, Liquid Medication | Class 1 | Dispenser, Liquid Medication – Feeding Syringes, Dispensers, 20ml Dosage cup | 2022 | 86 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Specimen Collection Holder, Labeled OR Promoted FOR, General Purpose,, Equipment, Laboratory,, A Specific Medical USE, Culture Plate and 4 more | 2007 | 72 |
| Forceps | Class 1 | 2010 | 99 | |
| Instrument, Manual, Surgical, General Use | Class 1 | Instrument, Manual, Surgical, General USE, Light handle cover | 2019 | 110 |
| Light, Surgical, Accessories | Class 2 | Lighted Handle Cover | 2025 | 21 |
| Micro Pipette | Class 1 | Gongdong Transfer Pipette | 2007 | 29 |
| Otoscope | Class 1 | 2011 | 43 | |
| Pack, Hot Or Cold, Disposable | Class 1 | Instant hot pack | 2024 | 176 |
| Pad, Alcohol, Device Disinfectant | Class U | Gongdong ALCOHOL PAD | 2021 | 49 |
| Retractor, Vaginal | Class 1 | Dispenser, Liquid Medication | 2023 | 8 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Shield, EYE, Ophthalmic (Including Sunlamp Protective Eyewear AND Post-Mydriatic Eyewear) | 2020 | 384 |
| Speculum, Ent | Class 1 | Disposable Otoscope Specula Cover, 2.5mm, Pediatric, Disposable Otoscope Specula Cover, 4.25mm, Adult | 2016 | 9 |
| Speculum, Rectal | Class 1 | 2017 | 8 | |
| Speculum, Vaginal, Nonmetal | Class 2 | Gongdong Disposabl, Vaginal Speculum, Disposable Vaginal Speculum | 2006 | 40 |
| System, Automated Platelet Aggregation | Class 2 | BAPA Tube for T-TAS 01 | 2020 | 1 |
| Tourniquet, Nonpneumatic | Class 1 | Latex-Free Tourniquet, Surgical tape | 2023 | 124 |
| Trap, Sterile Specimen | Class 2 | 2007 | 19 | |
| Tray, Surgical, Instrument | Class 1 | Placenta basin | 2026 | 105 |
| Tube, Collection, Capillary Blood | Class 1 | Capilary blood collection tube with sodium fluoride/potassium oxalate, Capilary Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.8%, Capilary Blood Collection Tubes 9NC Coagulation Sodium Citrate 3.2%;, Capilary blood collection tube with clot activator;Capilary blood collection tube no activator;, Capilary blood collection tube with EDTAK3;Capilary blood collection tube with Lithium heparin;, Capilary blood collection tube with clot activator and Gel;Capilary blood collection tube with EDTAK2; and 1 more | 2010 | 16 |
| Urine Collection Kit (Excludes Hiv Testing) | Class 1 | Urine Clean Catch Collection Set & Tube | 2026 | 7 |
Own-Brand Listings
Clearances
3 clearances name Zhejiang Gongdong Medical Technology Co., Ltd. as applicant. 2 are 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 |
|---|---|---|---|---|
| K253222 | 2025-12-22 | MMK | Traditional | This company |
| K220739 | 2022-11-17 | JSM | Traditional | This company |
| K201523 | 2020-11-12 | MMK | Traditional | This company |
| K082042 | 2008-09-03 | MMK | Traditional | Zhejiang Gongdong Medical Plastic Factory |
| K050887 | 2005-07-11 | HIB | Abbreviated | Zhejiang Gongdong Medical Plastic Factory |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1985 |
|---|---|
| Main products | Blood collection tubes, Lab consumables, Needles and needle holders, Sharp containers, Cell culture dishes |
| Certifications | ISO9001, ISO13485, CE, IPO listed company (2020) |
| Export markets | North America, Asia, South America, Africa, Europe |
Nearby Manufacturers
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.
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