FDA Registration
Active
🇨🇳 China
HUBEI V-MEDICAL PRODUCTS CO., LTD.
Reg #: 3014146451
·
FEI: 3014146451
·
Expires 2026
Products
46
Proprietary Names
90
Establishment Types
3
Classifications
46
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Registration Details
- Registration Name
- HUBEI V-MEDICAL PRODUCTS CO., LTD.
- Registration Number
- 3014146451
- FEI Number
- 3014146451
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.67, Xianhong Road, Xinli Renkou
- City
- Xiantao Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213598
Owner / Operator
- Firm Name
- Hubei V-Medical Products Co., Ltd.
- Operator Number
- 10056239
- Address
- No.67, Xianhong Road, Xinli Renkou
- City
- Xiantao
- State
- Hubei
- Postal Code
- 433012
- Country
- CN
- Correspondent
- Zhixiang Pan
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2025-11-28 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2024-11-26 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2025-11-28 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2025-11-28 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2024-11-26 |
| Elastomer, Silicone, For Scar Management | MDA | Class 1 | General, Plastic Surgery | No | 2025-11-28 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2017-11-20 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-11-28 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2026-03-03 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2024-11-26 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2024-11-26 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2017-11-20 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2017-11-19 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-11-26 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2024-11-26 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2026-03-03 |
| Gas, Collecting Vessel | KGK | Class 1 | Anesthesiology | No | 2025-11-28 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2021-12-24 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2024-11-26 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2021-01-28 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2026-03-03 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2026-03-03 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2021-12-24 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2021-01-28 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2025-11-28 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2024-11-26 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2024-11-26 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2025-11-28 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2026-06-10 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2024-11-26 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2025-11-28 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2025-11-28 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2019-11-27 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2025-11-28 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2021-01-28 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2019-02-10 |
| System, Skin Closure | MKY | Class 1 | General, Plastic Surgery | No | 2025-11-28 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2025-11-28 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-11-28 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2026-03-03 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2024-11-26 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2026-03-03 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2026-03-03 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2020-03-31 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2019-02-10 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2025-11-28 |
Proprietary Names
Saliva Ejector
Dressing kit
Collagen Wound Dressing
Healogics Derma Dress
Derma Ginate fluffy, in plastic cups, Healogics DermaGinate (calcium alginate), Hydra Lock SA, Healogics HydraLock SA,
Healogics Bordered foam, Healogics Bordered foam Fenestrated round, Healogics Sterile Bordered Gauze Dressing,
Sterile Bordered Gauze Dressing, Bordered foam, Sterile Bordered Gauze Dressing, Comfort Gauze Border,
Swabs applicators, swab sticks
Comfi Tape
absorbent pad (Sterilization and non-sterilization), Surgical operation towel (without x-ray detectable),
Non woven swab/Non woven pad (without x-ray detectable)
Non-woven swabs, gauze swabs, balls, Non woven ball (without x-ray detectable), absorbent pads,
Silicone Ag foam dressing
DEALMED: PRODUCT CODE:DM2201
PV-5878: Patterson Vet Face Mask; BA-032692: Butler Surgical Face Mask w/Ties; EC_9705 Surgical Face Masks;
PV-5894: Patterson Vet Surgical Face Mask w/Ties; Dynarex Isolation Mask with Earloop, Item 2208;
Dynarex Surgical Face Mask, Item 2205; Dynarex Procedure Face Mask, Item 2201;
Equipment cover
Alcohol pad
SILVER ALGINATE DRESSING 50X50MM, SILVER ALGINATE DRESSING 100X100MM, SILVER DRESSING 200X100MM
Non-woven swabs, gauze swabs, balls, Absorbent Surgical Gauze pad/Gauze swab/Gauze sponge (without x-ray detectable),
Absorbent Surgical Gauze ball/Peanuts ball (without x-ray detectable),
Absorbent Gauze rolls/Gauze slice/Zig-zag gauze (without x-ray detectable), ABD pad, ForSure ABD Pad
Surgical Lap sponge/Abdominal sponge (without x-ray detectable),
Surgical operation towel (with x-ray detectable), Surgical Lap sponge/Abdominal sponge (with x-ray detectable),
Absorbent Surgical Gauze pad/Gauze, swab/Gauze sponge (with x-ray detectable),
Absorbent Surgical Gauze ball/Peanuts ball (with x-ray detectable), Non woven ball (with x-ray detectable),
Absorbent Gauze rolls/Gauze slice/Zig-zag gauze (with x-ray detectable),
Non woven swab/Non woven pad (with x-ray detectable)
Forceps, Tweezers
Foley Ley Strap
RiteFix Retention Tape 1"x11yds
Tape, Adhesive wound dressing, DermaView Roll, Transparent Film Roll, Healogics HydraFoam
Dynarex Yougth Face Mask with Ear Loop, Item 2204
ForSure Face Mask with Tie, ForSure Face Mask with Earloop, ForSure Face Mask with Tie and Shield,
Drape; hand towel; Dynarex Yougth Face Mask with Ear Loop, Item 2207-YTBL;
ForSure Apron Disposable PE
Collagen Particles (Collagen Wound Dressing)
Disposable Tattoo Arm Sleeve Cover Barrier, ForSure Shoe Covers Non-Skid
DISPOSABLE SHOE COVER, Non-woven shoe cover, nonskid shoe cover, Cuff Barrier Sleeve(non-woven),
Triangular bandage
Surgical Gown, ForSure Surgical Gown
Yellow Highway Rescue Blanket; Shroud Kit; Body Bags; Linen Pack; Pillow case; Isolation Blanket, item 3450
Underpad; Premium Fitted Cot Sheet; Heavy Duty Cot Sheet w/elastic; Heavy Duty Fitted Cot Sheet; Premium Flat Cot Sheet;
ForSure Nurses Cap; ForSure Surgical Cap
BOUFFANT CAP; CLIP CAP; DISPOSABLE CAP; NON WOVEN CAP; NYLON CAP; PE CAP; Nurse cap; Surgeon cap
Specimen Container Non-Sterile
Tongue depressor
ICE BAG
Adhesive Tape Remover Pads, Healogics Adhesive Tape Remover Pads
Wrapping Drape
Hemostasis forceps, waste bag, gallipot, tray
Healogics Sting Free Prep Pads, Healogics Sting Free 3ml Wand, UnnaRite w, Zinc, UnnaRite w, Zinc Calamine,
Healogics Derma Prep Skin Prep Pads, Sting Free, Sting Free Prep Pads, Healogics Sting Free,
Healogics UnnaRite w, Zinc, Healogics UnnaRite w, Zinc Calamine
DEALMED: PRODUCT CODE: DM2201; Dynarex Procedure Face Mask with Ear Loop and Plastic Shield, Item 2202
Specimen Container Ster Indv, Specimen Cntainr Sterile Bulk
Knitted stockinette/Stockinettes; Cotton Stockinette
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
Oil Emulsion Non Adherent dressing, Petrolatum Gauze Dressing, Healogics Oil Emulsion Non Adherent dressing,
Healogics Hydra Foam
Healogics Comfort Foam 4x4 w, border, foam w, silicone,10, box, Healogics Comfort Foam 6x6 w, border,foam w, silicone,
Healogics Hydrocolloid Dermafilm, Healogics Derma Film Heel, Elbow, HL Derma Film X-Thin Clear Hydrocolloid,
Healogics DermaFilm, HL Derma Foam (non-adhesive foam dressing), Healogics Derma Foam (non-adhesive foam dressing),
lite thin foam W, silicone10bx, Healogics Derma Film HD 4x4,5, box, Healogic Derma Film X-Thin Clear Hydrocolloid,
Derma Film Thin, Hydrocolloid Dermafilm HD, Comfort Foam Border, Comfort Foam Border, Sacral, Comfort Foam,
silicone10bx, Healogics Comfort Foam 3x3W, border, lite thin foam W, silicone 10bx, Healogics Comfort Foam 4x4W, border,
10, box, Healogics Comfort Foam Border, Heel 5x8 5, box, Healogics Comfort Foam 2x2W, border, lite thin foam W,
Healogics Petrolatum Gauze Dressing, Derma View Transparent Dressing, Derma Foam Heel, Comfort Foam, foam w, silicone,
lite thin foam w, silicone, Healogics ComfiTel, Healogics ComfortFoam, Healogics ComfortFoam Ag,
Healogics Derma Foam Heel, Healogics Derma Foam Tracheostomy, Healogics Derma Levin, HL DermaView Transparent Dressing,
Isolation Smock; item 3451; ForSure Isolation gown
ISOLATION GOWN; Isolation gowns; Disposable Coveralls; Lab Coat; PP+PE Isolation gowns; Scrub Shirt; Scrub Pants;
Eye pad
StayStrips, Healogics StayStrips
Denture box
Healogics Aquaderm Hydrogel sheet,Healogics Derma Gauze Gel Dressing
Roosin Xeroform Petrolatum Dressing
4352, 4353, 4354 GAIT BELTS
Silicone Ag Foam Dressing with Border
Stainless steel scissors
Trach tube holder 9"length Ped, Trach tube holder 19"length Adult(2)
DynaLift Transport Unit
Face mask
2 Layer Compression Bandage System, Healogics FlexPress4, 4 Layer Compression Bandage System
Bandage, knitted stockinette, Stockinettes, FlexPress2 Lite 2 Layer Compression Bandage System, FlexPress2,
Healogics Derma View II (Frame Style) Dressing, HL Derma View II (frame style), Healogics DermaView II (frame style),
Healogics DermaView II, Healogics DermaView II Island Dressings, HL DermaView IV Transparent Dressing,
Healogics DermaView Roll, Transparent Film Roll
Derma View Dressing, Transparent Film, Derma View II Island Dressings, Healogics Derma View Transparent Dressing,
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device