BH Medical Products Co., Ltd
Changzhou City Jiangsu, CN
BH Medical Products Co., Ltd appears in FDA device records in Changzhou City Jiangsu, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for BH Medical Products Co., Ltd between 2015 and 2019. The busiest year on record is 2015, with 1. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | PEM | Substantially Equivalent | |
| K172280 | BH Sterilization Pouch | FRG | Substantially Equivalent | |
| K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | FXX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009307523 | 3009307523 | BH Medical Products Co., Ltd | No.90 Shenjiang villagers'group,Zhangjiacunwei,, Changzhou City Jiangsu 213024 CN | 2026 | and 27 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- EIFAccessories, Retractor, Dental
- LYUAccessory, Surgical Apparel
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KMEBedding, Disposable, Medical
- FYFCap, Surgical
- NRUChair, Dental, Without Operative Unit
- NNIContainer, Specimen, Non-Sterile
- FMHContainer, Specimen, Sterile
- EFNCotton, Roll
- EHKCup, Prophylaxis
- PEMDental Barriers And Sleeves
- KBLDepressor, Metal Tongue, Surgical
- FMADepressor, Tongue, Non-Surgical
- PUIDrape, Surgical, Exempt
- EHZEvacuator, Oral Cavity
- LZBFinger Cot
- EFLForceps, Dressing, Dental
- EYQGarment, Protective, For Incontinence
- NABGauze / Sponge,Nonresorbable For External Use
- GDYGauze/Sponge, Internal, X-Ray Detectable
- FMEGown, Examination
- EJBHandle, Instrument, Dental
- EGZHolder, Film, X-Ray
- DZNInstruments, Dental Hand
- FXXMask, Surgical
- EBHMaterial, Impression Tray, Resin
- DYNMouthpiece, Saliva Ejector
- DZMNeedle, Dental
- OEANon-Surgical Gown
- EFHPaper, Articulation
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- KYZSyringe, Irrigating (Non Dental)
- FSMTray, Surgical, Instrument
- NRDUnit, Operative Dental, Accessories
- ECBUnit, Syringe, Air And/Or Water
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain