Powered Mobility Scooter

by Intradin (Shanghai) Machinery Co., Ltd. EUDAMED510(k)

Active United States and European Union

Ref PMS105,GEUTS110Model "PMS101,GBTS010， PMS103,GEUT087，PMS102,GEUTS097 ， PMS104,GEUTS096，PMS105，GEUTS110"

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number69439407MobilityScooterRM Basic UDI-DI	Date20 May 2025Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK250027	Date21 Feb 2025Issued	StatusActive

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

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

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · 510(k)

Device Name: Powered Mobility Scooter
Model / Reference: "PMS101, GBTS010， PMS103, GEUT087，PMS102, GEUTS097 ， PMS104, GEUTS096，PMS105，GEUTS110", PMS105, GEUTS110

Primary DI / UDI-DI: 06943940700156
Basic UDI-DI: 69439407MobilityScooterRM
EMDN Code: Y122124 Electric scooters

Device Class: Class I
Market of Registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000034847
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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Transfer Floor Lift

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Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)

Class II
Powered Mobility Scooter (PMS105, GUT177, GCAT047)

Class II

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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