Wheelchair

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Device Name

Wheelchair

Model / Reference

YJ-037/AL-001/AL-002/YJ-059/S2/S5/AL-BL08/AL-005, YJ-059 Steel Wheelchair

Primary DI / UDI-DI

06974231101475

Basic UDI-DI

697423110ASSUREWCBX

EMDN Code

Y122103 Push wheelchairs

Device Class

Class I

Market of Registration

Spain

EUDAMED SRN

CN-MF-000001076

Authorised representative

Lotus NL B.V. NL-AR-000000121

• Rollator

  Class I

  CE/MDR

• Multifunctional wheelchair (YJ-059)

  Class I

  FDA 510(k) K261919 Active Cleared 16 Sep 2026

• Bariatric Heavy Duty Wheelchair (YJ-010V)

  Class I

  FDA 510(k) K260141 Active Cleared 15 Sep 2026

• Reclining wheelchair (YJ-013L)

  Class I

  FDA 510(k) K260144 Active Cleared 15 Sep 2026

• YJ-K1K2 Wheelchair (YJ-013F)

  Class I

  FDA 510(k) K260145 Active Cleared 15 Sep 2026

• Wheelchair

  Class I

  CE/MDR

See all devices from Zhenjiang Assure Medical Equipment Co., Ltd →