Alleva Medical Limited
China CN-MF-000018963 Last updated 23 May 2026
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- Devices
- 15
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
Chest Drain Basket with Clamp & Steel Hanger Ref HC063-0001
Vide® 2000ml Bag Suction Liner Ref MI287-0008
Vide® 1500ml Bag Suction Liner Ref MI286-0008
Vide® 1500ml Suction Rigid Canister Ref MI202-0004
Vide® 1000ml Bag Suction Liner with Solidifiers Ref MI285-0015
Vide® 1500ml Suction Rigid Canister Ref MI201-0002
Chest Drain Basket with Clamp Ref HC063-0002
Vide® 1500ml Bag Suction Liner with Solidifiers Ref MI286-0015
Vide® 1200ml Suction Rigid Canister Ref MI056-0007
Vide® Pediatric Dry Suction/Water Seal Chest Drain Ref ST424-0001
Vide® Breeze Chest Drain Valve Ref ST425-0001
Vide® Ref ST381-0001
Vide® Ref ST380-0001
EUDAMED certificates
UDEM Adriatic d.o.o. 2696 1 certificate
- M.2024.MDR.1041 Amended
Quality management system EU MDR
- Issued
- 24 Sep 2026
- Expires
- 25 Jun 2029
- Reason
- Other
Related companies
Authorised representatives
Notified bodies
- UDEM Adriatic d.o.o. 2696
FDA establishments
- Alleva Medical Ltd Shatin, N.T. · HK FEI 3014947294
- Alleva Medical, Ltd. HK
What Alleva Medical Limited makes
Alleva Medical Limited manufactures chest drainage systems, including pediatric and adult suction devices for evacuating air or fluid from the thoracic cavity, as well as one-way valves for chest tube management. The company also produces negative pressure wound therapy pumps designed for wound healing applications, delivering controlled suction to promote tissue regeneration.
The company’s products are classified under EU medical device regulations as Class I and Class IIa, with relevant details registered in the eudamed database. The manufacturer is based in China and adheres to regulatory requirements for devices intended for the European market.
Frequently asked questions
What types of medical devices does Alleva Medical Limited manufacture?
Alleva Medical Limited specializes in chest drainage systems, including pediatric and adult suction devices like the Vide® Pediatric Dry Suction/Water Seal Chest Drain, which are designed to remove air or fluid from the thoracic cavity. Additionally, the company produces one-way valves for chest tube management, such as the Vide® Breeze Chest Drain Valve, and negative pressure wound therapy pumps like the extriCARE®, which apply controlled suction to aid wound healing.
Where is Alleva Medical Limited based, and what regulatory markets do its devices serve?
Alleva Medical Limited is headquartered in China. While the company’s devices are designed with regulatory requirements in mind, their products are specifically registered in the EU’s eudamed database, indicating compliance with European medical device regulations for market placement there.
How are Alleva Medical Limited’s devices classified under EU medical device regulations?
Alleva Medical Limited’s devices fall under EU medical device classifications as either Class I or Class IIa. This classification is determined by factors like the intended use, potential risks, and the duration of contact with the body. For example, chest drainage systems and negative pressure wound therapy pumps are typically assessed based on their risk profile, with Class IIa indicating a moderate risk requiring additional scrutiny.
Which regulatory registries list Alleva Medical Limited’s devices?
Alleva Medical Limited’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of devices placed on the European market, allowing healthcare professionals and regulators to verify key details like manufacturer information and device classifications.
Information
- Country
- China
- Address
- Suite M-Q,12th Floor,Kings Wing Plaza 2,1 On Kwan St. Shek Mun,Shatin,N.T. HK-Hongkong China, Hong Kong, China
- Website
- allevamedical.com
- [email protected]
- PRRC contact
- kf chan
- EUDAMED SRN
- CN-MF-000018963
- DUNS number
- 669361099