FDA Registration
Active
🇨🇳 China
ALLEVA MEDICAL (D.G.) LTD
Reg #: 3010308146
·
FEI: 3010308146
·
Expires 2026
Products
13
Proprietary Names
58
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- ALLEVA MEDICAL (D.G.) LTD
- Registration Number
- 3010308146
- FEI Number
- 3010308146
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 76 San Lian Nan Road, Lu Wu Administration District,, Changping Town
- City
- Dongguan City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K140634
Owner / Operator
- Firm Name
- ALLEVA MEDICAL LTD
- Operator Number
- 10045844
- Address
- Suite M-Q, 12th Floor, Kings Wing Plaza, 2, 1 On Kwan St. Shek Mun,
- City
- Shatin, N.T.
- State
- HK-NOTA
- Postal Code
- 00000
- Country
- HK
- Correspondent
- Max Choi
US Agent
- Business Name
- Alleva Medical devices
- Contact Name
- Max Choi
- Address
- 1050 W Central Ave Ste B
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 657 5379351
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reservoir, Blood, Cardiopulmonary Bypass, Exempt | PTN | Class 2 | Cardiovascular | No | 2021-11-11 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2022-01-12 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2018-02-18 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2026-05-13 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2019-09-11 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2014-12-22 |
| Apparatus, Suction, Patient Care | DWM | Class 2 | Cardiovascular | No | 2021-01-02 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2021-07-14 |
| Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | PNG | Class 2 | Gastroenterology, Urology | No | 2023-11-28 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-30 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2014-01-05 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2018-08-07 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2014-01-06 |
Proprietary Names
Stimfix Anchoring System
extriCARE 3600, canister and Foam Kits (EC3600-100C-E, EC-FOAM-S-E, EC-FOAM-M-E, EC-FOAM-L-E, EC-DOME, EC-DRAPE)
extriCARE 3600 Negative Pressure Wound Therapy System 1000cc Collection Canister (EC3600-1000C-E)
Yarrow Woundbrush
extriCARE 2400 Negative Pressure Wound Therapy System - 250cc and 400cc collection canister (EC2400-400C-E)
extriCARE 3600 Negative Pressure Wound Therapy System
Plexus RP100 DVT Prevention System
Maxson Disposable Eye Shield
Maxson Disposable Face Shield
AIROS 8P Sequential Compression Device
extriCARE 1000 Negative Pressure Wound Therapy System (EC1000) and 50cc canister (EC1000-CAN)
1000mL "Bag" Suction Liner (MI285-0008)
1500mL Suction Canister (MI358-0013)
3000mL Suction Lid Liner (MI248)
1500mL Rigid Suction Canister (MI202-0004)
800mL Rigid Suction Canister (MI055-0012)
Rigid High Flow Suction Canister (MI278)
Vide Sterile End Cap for In-Line Connector (ST380-0900)
1500mL "Bag" Suction Liner (MI286-0008)
1500mL Suction Lid Liner (MI243)
1800mL Suction Canister (MI130)
Hanger Plate (MI167)
Vide Shore Pediatric Dry Suction Water Seal Chest Drain (ST424-0001)
3000mL Suction Canister (MI302-0013)
Vide Shore Dry Suction / Water Seal Chest Drain (ST381-0001)
2000mL "Bag" Suction Liner with solidifier (MI287-0015)
1000mL "Bag" Suction Liner with solidifier (MI285-0015)
Y-Tubing Set for Dual Catheter Connection (ST380-0400)
Rigid High Flow Suction Canister (MI277)
Y-Tubing Set for Suction-Dual Drain Connection (ST380-0500)
1000mL Suction Lid Liner (MI217)
In-line Needleless Sampling Port Connector (ST380-0200)
Transition tube with Luer Connector (ST380-0600)
1500mL "Bag" Suction Liner with solidifier (MI286-0015)
Vide Wave Pediatric Water Seal Chest Drain (ST422-0001)
Chest Drain Basket with Clamp (HC063-0002)
Vide Sand Dry Seal Chest Drain (ST382-0001)
Chest Drain Basket with Hanger and Clamp (HC063-0001)
8-12Fr Step-down connector (ST380-0100)
1800mL Suction Liner (MI158)
Vide Breeze Chest Drain Valve (ST425-0001)
Patient stepped connector (for 16-40Fr catheter) (ST380-0300)
1000mL Suction Canister (MI129-0013)
Vide Wave Three-Chamber Water Seal Chest Drain (ST380-0001)
Vide Wave Three-Chamber Water Seal Chest Drain, with inline sampling port connector (ST380-0006)
3000mL "Bag" Suction Liner (MI288-0008)
1200mL Rigid Suction Canister (MI056-0012)
2000mL "Bag" Suction Liner (MI287-0008)
1300mL Suction Liner (MI157)
Vide Manual Suction Bulb, Non-Sterile (ST380-0700)
Vide Shore Dual Chamber Dry Suction Water Seal Drain (ST423-0001)
3000mL "Bag" Suction Liner with solidifier (MI288-0015)
3200mL Suction Liner (MI159)
1300mL Suction Canister (MI129)
3200mL Suction Canister (MI131)
2000mL Suction Canister (MI301-0013)
extriCARE 2400 NPWT Pump and canister (2400, EC2400-400C-E) ; Bandage Dressings (EC2400-SO/MN/LO/IM-E)
extriCARE 3000 Negative Pressure Wound Therapy System; extriCARE 3000 100cc and 400cc canister
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device