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Ankle Brace And Night Splint

EUDAMED

Class I (EU MDR)

Ref FG-6004 SModel 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-6004 S EUDAMED

Identifiers

Primary DI / UDI-DI
06976009959356 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

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

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

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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 285aa47a-571a-498b-92f8-610ffc73b0c1 61 fields · synced Oct 8, 2026