Portable Electro-Stimulation Terapy Device

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref NAModel LGT-231, LGT-232, LGT-233, LGT-235510(k) K182108

by Guangzhou Longest Science & Technology Co., Ltd.

Identity

Trade Name: Portable Electro-Stimulation Terapy Device EUDAMED
Device Name: Portable Electro-Stimulation Terapy Device EUDAMED
Model / Reference: LGT-231, LGT-232, LGT-233, LGT-235 EUDAMED
NA EUDAMED

Identifiers

Primary DI / UDI-DI: D-CNMF000013828230F3 EUDAMED
Basic UDI-DI: B-CNMF000013828230F3 EUDAMED
EMDN Code: Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Italy EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Portable Electro-Stimulation Terapy Device by Guangzhou Longest Science & Technology Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K182108	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K182020	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-CNMF000013828230F3	Class IIa	Active

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Manufacturer

Manufacturer: Guangzhou Longest Science & Technology Co., Ltd.
EUDAMED SRN: CN-MF-000013828
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (3)

EUDAMED f671916b-b459-42d7-8804-3ac9286d90da 85 fields · synced Jul 25, 2026
EUDAMED f671916b-b459-42d7-8804-3ac9286d90da-1 61 fields · synced Jul 25, 2026
FDA 510(k) K182108 1 fields · synced May 18, 2026