Nanning Tecbod Biological Technology Co., Ltd.
Registered establishment in Nanning, Guangxi, China. 51 device types, 2 clearances.
Nanning Tecbod Biological Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pad, Eye, Cotton, Roll and 49 other device types. Its earliest product listing with the FDA dates from 2020.
51device types registered with the FDA
2510(k) clearances
Registration
| Registered name | NANNING TECBOD BIOLOGICAL TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016763307 |
| FEI number | 3016763307 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 南宁腾科宝迪生物科技有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Nanning |
|---|---|
| Province | Guangxi |
| Address | Room 601 Floor 6, B2 Building, No 19 Guokai Dadao |
| Postal code | 530033 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Glove | 2020 | 439 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Laryngeal mask; Anaesthetic mask | 2022 | 84 |
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | Class 1 | Quantitative PCR, Real-time fluorescent quantitative PCR analyzer | 2022 | 9 |
| Analyzer, Chemistry, Centrifugal, For Clinical Use | Class 1 | Automatic chemistry analyzer | 2022 | 3 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Non-woven swabs, Swab stick, Cotton swabs/Cotton applicators | 2022 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Cotton swab stick (sterilization) | 2022 | 100 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | Urine bag | 2022 | 47 |
| Bandage, Elastic | Class 1 | Cohesive bandage/ P.O.P bandage/Stockinette bandage, Wrist band, Head band, Elastic bandage, Self-adherent bandage,, Orthopaedic pad, Gauze bandage/Conforming elastic bandages/Crepe bandages/Medical bandage/Tubular bandage/, Gauze rolls | 2022 | 280 |
| Blade, Scalpel | Class 1 | Scalpel, Disposable surgical blades | 2022 | 41 |
| Cap, Surgical | Class 1 | Medical cap | 2020 | 178 |
| Catheter And Tip, Suction | Class 2 | Suction catheter, Closed suction catheter | 2022 | 70 |
| Catheter, Nasal, Oxygen | Class 1 | Nasal oxygen cannula, Oxygen tube | 2022 | 14 |
| Catheter, Ventricular, General & Plastic Surgery | Class 1 | Nelation catheters, Stomach tubes, Foley catheter(latex), Extension tubes | 2022 | 7 |
| Catheters, Suction, Tracheobronchial | Class 1 | Suction catheter, Closed suction cetheters | 2022 | 93 |
| Clinical Sample Concentrator | Class 1 | Disposable sampling collection kit, Specimen collection kit, Swab sampling kit, Saliva collection device;, Genomic DNA purification kit, Saliva DNA sample collector, Automatic nucleic acid purification instrument,, DNA/RNA extraction/purification kit | 2022 | 27 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Disposable urine collection bag, Ostomy wipe off spray | 2022 | 51 |
| Container, Specimen Mailer And Storage, Non-Sterile | Class 1 | Biohazard bag, Drawstring bag, Specimen container, Sampling tube, Sampling collector, Biopsy cassette/embedding cassette, Specimen bag, | 2022 | 51 |
| Container, Specimen, Non-Sterile | Class 1 | Buccal cell collection Device (Swab), Medical microbiological swab caps, Centrifuge tube, Test tube, Sample cups, Reagent bottle& surveying cup, Dentures, Dentures cup, Saliva collection kit, | 2022 | 115 |
| Cotton, Roll | Class 1 | Cotton ball, Cotton roll | 2022 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe cover | 2020 | 176 |
| Cup, Menstrual | Class 2 | Menstrual cup | 2022 | 20 |
| Depressor, Metal Tongue, Surgical | Class 1 | Wooden tongue depressor | 2022 | 10 |
| Depressor, Tongue, Non-Surgical | Class 1 | Tongue depressor | 2022 | 100 |
| Dish, Tissue Culture | Class 1 | Deep well plate, Cell culture plate, Cell culture flask, Cell culture dish, Petri dish, Culture plate/tissue culture plate, | 2022 | 30 |
| Disinfectant, Medical Devices | Class 1 | Non-woven wipe, Wet wipes, Anticeptic wipes, Alcohol prep Pad, Povidone Iodine Prep Pads, Hand sanitizer, Handkerchiefs | 2022 | 197 |
| Drape, Surgical, Ent | Class 2 | Medical pad | 2022 | 5 |
| Dress, Surgical | Class 1 | Disposable surgical gown,surgical gown, Nonwoven coverall | 2020 | 71 |
| Dressing, Compression | Class 1 | Bandage compress, Burn dressing, Non-adherent pad, Sterile absorbent compress, Sterile gauze swabs,, Dressing bandage, Medical sterile PU dressing, Tattoo bandage, Sterile and non-sterile dressing, Sterile and non-sterile pads | 2022 | 87 |
| Dressing, Wound, Hydrophilic | Class 1 | Adhesive bandage or wound plaster, Foam wound dressing, Alginate wound dressing, Non-woven dressing, IV dressing,, Hydrocolloid adhesive bandage, Acne pacth, Adhesive bandage | 2022 | 195 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Automatic mounting apparatus, Staining solution, Plastic test tube, Filter tips, Foreign Exporter, Cryogenic tubes, Automatic tissue staining apparatus,, Test tubes, Cryotubes/freezing tube, silica gel stopple, PCR tube, PCR plate, PCR sealing film, Micro centrifuge tube,, Conical centrifuge tube, Deep well plate, Screw cap tube, Cryogenic vials, Water test strips, Glass test tube; | 2022 | 72 |
| Fiber, Medical, Absorbent | Class 1 | Underpad, Absorbent gauze products | 2022 | 172 |
| First Aid Kit With Drug | Class N | First aid kit with drug | 2022 | 57 |
| Garment, Protective, For Incontinence | Class 1 | Disposable baby diaper/Adult diapers, Disposable baby Pants, Incontinence womens panties, Incontinence mens panties,, Diapers, Bladder control pad,Period pants, Underpad | 2022 | 181 |
| Gown, Examination | Class 1 | Pants, PE rain coat, Patient gown, CPE gown, Examination gown, Scrub Suits | 2022 | 109 |
| Gown, Isolation, Surgical | Class 2 | Disposable Isolation Gown | 2023 | 21 |
| Gown, Surgical | Class 2 | Disposable Surgical Gown | 2024 | 68 |
| Infusor, Pressure, For I.V. Bags | Class 1 | Infusion bags | 2022 | 25 |
| Joint, Knee, External Brace | Class 1 | Elbow compression brace, Knee support, Hinged knee brace, Back stretcher, Wrist straps; Groin support, Copper elbow Immoblizer, | 2022 | 137 |
| Mask, Oxygen | Class 1 | CPAP Mask | 2024 | 126 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Nebulizer mask | 2022 | 57 |
| Non-Surgical Gown | Class 1 | Protective clothing, Isolation Gown,Clean air suits | 2020 | 318 |
| Pad, Eye | Class 1 | Sterile eye pad, Eye covering | 2022 | 100 |
| Pad, Menstrual, Unscented | Class 1 | Urine sheets, Sanitary napkins, Maternity towels, Pads/Panty liner, Maternity pad | 2022 | 132 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Medical goggle, Eye patch | 2020 | 384 |
| Shield, Protective, Personnel | Class 1 | Face-Shield | 2020 | 78 |
| Splint, Hand, And Components | Class 1 | Wrist Support, Boxer splint, Finger splint, Gel wrist support | 2022 | 144 |
| Stethoscope, Manual | Class 1 | Diagnostics Stethoscopes | 2022 | 64 |
| Stocking, Medical Support (For General Medical Purposes) | Class 1 | Mixed case of elastic supports (elastic wrist support, elastic elbow support, elastic calf support,, elastic ankle support, elastic knee support) | 2022 | 76 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | Vaccum blood collection tube | 2022 | 31 |
| Tape And Bandage, Adhesive | Class 1 | Medical adhesive tape, Liquid transfusion plaster, Catheter fixation, Medical double sided tape, Roller bandage | 2022 | 353 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet, Silicone tourniquet | 2022 | 124 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233068 | 2024-03-29 | FYA | Traditional | This company |
| K223467 | 2023-02-10 | FYC | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 30000 square meters (planned industrial park) |
|---|---|
| Main products | Medical fabrics, Medical uniforms, Medical catheters, Pandemic control materials, Eye care products |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Guangxi Ehall Medical Technology Co., Ltd. | 17 |
| Nanning Sixtant Biotechnology Co., Ltd. | 13 |
| Guang XI Fulaiming Biopharmaceutics Co., Ltd. | 12 |
| Guangxi Dezhiran Biotechnology Co., Ltd. | 4 |
| Nanning Baolai Medical Instrument Co., Ltd. | 4 |
| China Star Products (Binyang) Limited | 4 |
| Guangxi Shuya Health Care-Products Co., Ltd. | 3 |
| Acumen Houseware Industry (Nanning) Co., Ltd. | 2 |
| Nanning VV Dental 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.