Data / Medical devices / China / BH Medical Products Co., Ltd
BH Medical Products Co., Ltd: FDA-registered device maker in Changzhou City Jiangsu, China, 3 510(k) clearances
BH Medical Products Co., Ltd is registered with the FDA (registration 3009307523) in Changzhou City Jiangsu, China. It lists 37 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 10, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009307523
- Address
- No.90 Shenjiang villagers'group,Zhangjiacunwei, Xilin Street,Zhonglou District, Changzhou City Jiangsu, China, 213024
- Owner or operator
- BH Medical Products Co., Ltd (10036911)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 6, 2011
- Registered through
- 2026
- Brand names listed
- Adult Diaper Brief, Adult Diaper Form, Adult Diaper Pad, Adult Diaper Pull-up, Air/Water Syringe Tips, Articulating paper, BH Medical Dental Barrier Sleeves and Barrier Film, Barrier Film and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Absorber, Saliva, Paper | KHR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Accessories, Retractor, Dental | EIF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Chair, Dental, Without Operative Unit | NRU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dental Barriers And Sleeves | PEM | 2 | Manufacturer | accessdata.fda.gov |
| Depressor, Metal Tongue, Surgical | KBL | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Finger Cot | LZB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| September 10, 2019 | K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | PEM | Substantially Equivalent | Bh Medical Products Co., Ltd. | accessdata.fda.gov |
| August 3, 2018 | K172280 | BH Sterilization Pouch | FRG | Substantially Equivalent | Bh Medical Products Co., Ltd. | accessdata.fda.gov |
| June 22, 2015 | K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | FXX | Substantially Equivalent | Bh Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Garment, Protective, For Incontinence
- All makers of Evacuator, Oral Cavity
- All makers of Gown, Examination
- All makers of Unit, Syringe, Air And/Or Water
- All makers of Drape, Surgical, Exempt
- All makers of Material, Impression Tray, Resin
Updated September 10, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.