Air Compression Recovery System

by Shenzhen Dongjilian Medical Tech Co., Ltd

Ref M2006, M2005Model M2005,M2006

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233536↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number69405258M2005E5 Basic UDI-DI	Date25 Mar 2026Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK233536	Date16 Dec 2023Issued	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

United States FDA 510(k) Active
European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Model / Reference: M2005, M2006

Primary DI / UDI-DI: 06940525820063, 06940525820056
Basic UDI-DI: 69405258M2005E5
EMDN Code: Z120607 Pneumatic compression equipment

Device Class: Class IIa
EU market of registration: Iceland

Manufacturer details

EUDAMED SRN: CN-MF-000035462
Authorised representative: Wellkang Ltd XI-AR-000001836

Other devices from Shenzhen Dongjilian Medical Tech Co., Ltd

Air Compression Leg Massager (Models S9036C, S9036B, S9036A)

Class II

Properties

Other properties (13)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No