Ankle Brace And Night Splint

EUDAMED

Class I (EU MDR)

Ref FG-A004 UModel FG-1002,FG-1002-1,FG-1003,FG-1004,FG-1007,FG-1007-2,FG-1007-3,FG-1011,FG-1026,FG-1021,FG-1022,FG-6002,FG-6004,FG-6005,FG-6008,FG-6023,FG-6024,FG-6026,PE-8806,FG-PED014,FG-1247,FG-A001,FG-A002,FG-A003,FG-A004,FG-A005,FG-A005-1,etc.

by Xiamen LongStar Medical Equipment Co., Ltd

Identity

Device Name: Ankle Brace And Night Splint EUDAMED
Model / Reference: FG-1002,FG-1002-1,FG-1003,FG-1004,FG-1007,FG-1007-2,FG-1007-3,FG-1011,FG-1026,FG-1021,FG-1022,FG-6002,FG-6004,FG-6005,FG-6008,FG-6023,FG-6024,FG-6026,PE-8806,FG-PED014,FG-1247,FG-A001,FG-A002,FG-A003,FG-A004,FG-A005,FG-A005-1,etc. EUDAMED
FG-A004 U EUDAMED

Identifiers

Primary DI / UDI-DI: 06976009959592 EUDAMED
Basic UDI-DI: 697600995ABANSJV EUDAMED
EMDN Code: Y090618 LEG AND KNEE PROTECTIONS (INCLUDING SOCKS FOR AMPUTATED LEGS) EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Austria EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Ankle Brace And Night Splint by Xiamen LongStar Medical Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	697600995ABANSJV	Class I	Active

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Manufacturer

Manufacturer: Xiamen LongStar Medical Equipment Co., Ltd
EUDAMED SRN: CN-MF-000034315
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (1)

EUDAMED 7bf67b43-bdcb-4250-900a-79ecb5d4ee6f 61 fields · synced Oct 7, 2026