BH Medical Products Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 37 device types, 3 clearances.
BH Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Finger Cot, Cotton, Roll and 35 other device types. Its earliest product listing with the FDA dates from 2011.
37device types registered with the FDA
3510(k) clearances
Registration
| Registered name | BH Medical Products Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009307523 |
| FEI number | 3009307523 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No.90 Shenjiang villagers’group,Zhangjiacunwei, |
| Postal code | 213024 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | Dental Bib | 2015 | 86 |
| Accessories, Retractor, Dental | Class 1 | Mouth Prop, lip ring retractor | 2014 | 37 |
| Accessory, Surgical Apparel | Class 1 | nonwoven shoe cover, hand and arm sleeve protection | 2011 | 439 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | cotton tip applicators | 2023 | 186 |
| Bedding, Disposable, Medical | Class 1 | crepe paper rolls, exam table paper crepe, pillowcase, drape sheet, table paper, exam table paper smooth and 5 more | 2012 | 308 |
| Cap, Surgical | Class 1 | tie-on surgical cap, disposable cap, lab jackets, lab coats | 2011 | 178 |
| Chair, Dental, Without Operative Unit | Class 1 | tray paper, headrest cover, Tray Cover | 2015 | 38 |
| Container, Specimen, Non-Sterile | Class 1 | Specimen Container, medicine cup, plastic cup, drinking cup, mixing well, Paper Cup and 2 more | 2011 | 115 |
| Container, Specimen, Sterile | Class 1 | Stoolcontainer, Specimen Container, Urine Container | 2025 | 79 |
| Cotton, Roll | Class 1 | cotton rolls | 2011 | 107 |
| Cup, Prophylaxis | Class 1 | Prophy cup | 2023 | 49 |
| Dental Barriers And Sleeves | Class 2 | BH Medical Dental Barrier Sleeves and Barrier Film, Dental Barriers and Sleeves, Barrier Sleeves, Barrier Film | 2019 | 12 |
| Depressor, Metal Tongue, Surgical | Class 1 | Ear Nose & Throat | 2024 | 10 |
| Depressor, Tongue, Non-Surgical | Class 1 | Tongue depressor and finger splint | 2025 | 100 |
| Drape, Surgical, Exempt | Class 2 | drape sheet | 2023 | 107 |
| Evacuator, Oral Cavity | Class 1 | HVE tips | 2011 | 49 |
| Finger Cot | Class 1 | hand and arm sleeve protection | 2025 | 29 |
| Forceps, Dressing, Dental | Class 1 | Bib Clip | 2025 | 22 |
| Garment, Protective, For Incontinence | Class 1 | Adult Diaper Brief, Adult Diaper Pad, Adult Diaper Form, Adult Diaper Pull-up | 2023 | 181 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | cotton spunlace sponge, nonwoven sponge, sponge | 2011 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | abd pad | 2025 | 67 |
| Gown, Examination | Class 1 | exam cape, exam gown | 2011 | 109 |
| Handle, Instrument, Dental | Class 1 | Micro Brush Applicators | 2015 | 29 |
| Holder, Film, X-Ray | Class 1 | bite-wing tabs | 2024 | 40 |
| Instruments, Dental Hand | Class 1 | Wedge | 2015 | 64 |
| Mask, Surgical | Class 2 | shield mask, Mask, level 2 HMT earloop mask | 2015 | 125 |
| Material, Impression Tray, Resin | Class 1 | impression tray, bite tray | 2015 | 41 |
| Mouthpiece, Saliva Ejector | Class 1 | saliva ejector, aspirator tip, HVE tip | 2011 | 68 |
| Needle, Dental | Class 1 | Needle sheath card, needle sheath prop | 2024 | 56 |
| Non-Surgical Gown | Class 1 | isolation gown, gown | 2011 | 318 |
| Paper, Articulation | Class 1 | Articulating paper | 2025 | 12 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | face shield, Safety Goggles, Spectacles | 2015 | 384 |
| Syringe, Irrigating (Non Dental) | Class 1 | Utility Syinges Curved, Pre-Bent Dispensing Tips | 2015 | 110 |
| Tray, Surgical, Instrument | Class 1 | dental flat tray | 2014 | 105 |
| Unit, Operative Dental, Accessories | Class 1 | mixing sticks, sterilization tape, light protective hand shield, paper wrapper, tray cover ritter, indicator tape and 7 more | 2011 | 65 |
| Unit, Syringe, Air And/Or Water | Class 1 | Air/Water Syringe Tips | 2011 | 56 |
| Wrap, Sterilization | Class 2 | Sterilization Pouch | 2018 | 38 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K190484 | 2019-09-10 | PEM | Traditional | This company |
| K172280 | 2018-08-03 | FRG | Traditional | This company |
| K133070 | 2015-06-22 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1999 |
|---|---|
| Main products | Dental bibs, Sterilization pouches, Face masks, Disposable medical products |
| Certifications | ISO13485, CE, FDA, 510K |
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.
The manufacturer named here can complete this record.