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Alleva Medical Limited

China CN-MF-000018963 Last updated 23 May 2026

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Devices
15
Registries
EUDAMEDGUDIDFDA
FDA recalls
0

Catalogue15

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

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

Authorised representatives

Notified bodies

FDA establishments2

Registered with the FDA under this company group, matched by name.

  • 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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

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.

AI-generated from registry data and not verified by a human reviewer.

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
PRRC contact
kf chan
EUDAMED SRN
CN-MF-000018963
DUNS number
669361099