Data / Medical devices / China / Hubei V-Medical Products Co., Ltd.
Hubei V-Medical Products Co., Ltd.: FDA-registered device maker in Xiantao Hubei, China, 9 510(k) clearances
Hubei V-Medical Products Co., Ltd. is registered with the FDA (registration 3014146451) in Xiantao Hubei, China. It lists 46 device types. The FDA files 9 510(k) clearances under its listings, the newest dated April 25, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014146451
- Address
- No.67, Xianhong Road, Xinli Renkou, Xiantao Hubei, China, 433012
- Owner or operator
- Hubei V-Medical Products Co., Ltd. (10056239)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 19, 2017
- Registered through
- 2026
- Brand names listed
- 10, box, Healogics Comfort Foam Border, Heel 5x8 5, box, Healogics Comfort Foam 2x2W, border, lite thin foam W,, 2 Layer Compression Bandage System, Healogics FlexPress4, 4 Layer Compression Bandage System, 4352, 4353, 4354 GAIT BELTS, Absorbent Gauze rolls/Gauze slice/Zig-zag gauze (with x-ray detectable),, Absorbent Gauze rolls/Gauze slice/Zig-zag gauze (without x-ray detectable), ABD pad, ForSure ABD Pad, Absorbent Surgical Gauze ball/Peanuts ball (with x-ray detectable), Non woven ball (with x-ray detectable),, Absorbent Surgical Gauze ball/Peanuts ball (without x-ray detectable),, Absorbent Surgical Gauze pad/Gauze, swab/Gauze sponge (with x-ray detectable), and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| April 25, 2024 | K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | KGN | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| September 20, 2022 | K213598 | LUOFUCON Collagen Wound Dressing | KGN | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| September 13, 2019 | K181478 | Roosin Xeroform Petrolatum Dressing | FRO | Substantially Equivalent | Roosin Medical Co., Ltd. | accessdata.fda.gov |
| January 16, 2019 | K173847 | Disposable Ultra Reinforced Surgical Gown | FYA | Substantially Equivalent | Xiantao Rayxin Medical Products Co., Ltd. | accessdata.fda.gov |
| March 30, 2017 | K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| August 17, 2016 | K160022 | LUOFUCON Silicone Ag foam dressing | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| June 15, 2016 | K153496 | Disposable Surgical Face Mask | FXX | Substantially Equivalent | Xiantao Rayxin Medical Products Co., Ltd. | accessdata.fda.gov |
| February 14, 2013 | K120181 | LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM | FRO | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 2, 1994 | K931580 | DISPOSABLE SURGICAL MASK (MODIFIED) | FXX | Substantially Equivalent | Bam Corp., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Surgical Gown
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- All makers of Bandage, Cast
- All makers of Depressor, Tongue, Non-Surgical
- All makers of System, Skin Closure
- All makers of Bandage, Elastic
Updated April 25, 2024. 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.