Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010308146

FEI Number

3010308146

Entity Name

ALLEVA MEDICAL (D.G.) LTD

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

76 San Lian Nan Road, Lu Wu Administration District,, Changping Town, Dongguan City Guangdong 523587, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ALLEVA MEDICAL LTD (Owner Number: 10045844)

Owner / Operator Contact Address

Suite M-Q, 12th Floor, Kings Wing Plaza, 2, 1 On Kwan St. Shek Mun,, Shatin, N.T., HK-NOTA 00000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTN	Reservoir, Blood, Cardiopulmonary Bypass, Exempt	Cardiovascular	Class 2	870.4400	2021-11-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-01-12
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-02-18
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-02-18
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2026-05-13
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-02-18
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2018-02-18
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2019-09-11
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2014-12-22
DWM	Apparatus, Suction, Patient Care	Cardiovascular	Class 2	870.5050	2021-01-02
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2024-10-17
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2021-07-14
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2023-11-28
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-30
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2023-01-13
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-03-09
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2014-01-05

Official Correspondent

Max Choi

US Agent Details

Max Choi Business: Alleva Medical devices Email: max@allevamedical.com Phone: (657) 5379351

Related Public Records

Same Entity

ALLEVA MEDICAL LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014947294	ALLEVA MEDICAL LTD	Shatin, N.T., HK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010308146. Last updated year: 2026. Please use registration number 3010308146 when referencing this establishment in official correspondence.