lumark

by Lu Mark Healthcare Co., Ltd. 10 variants

Ref LM-908

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number471987906A010DS Basic UDI-DI 04719879060102UDI-DI	Date14 Jul 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Cold Compression Therapy for Spine
Model / Reference: LM-908

Primary DI / UDI-DI: 04719879060102
Basic UDI-DI: 471987906A010DS
EMDN Code: M9001 Cryotherapy and thermotherapy devices

Device Class: Class I
EU market of registration: France

Manufacturer details

EUDAMED SRN: TW-MF-000015951
Authorised representative: MedNet EC-REP GmbH DE-AR-000000002

Other devices from Lu Mark Healthcare Co., Ltd.

U-Sport Ice Bag L, Ice and Warm Bag 11 inches

Class I
Ice Bag Holder

Class I
U-Sport Ice Bag M, Ice and Warm Bag 9 inches

Class I
Ice and Warm Bag 11 inches with Strap

Class I
U-Sport Ice Bag S, Ice and Warm Bag 6 inches

Class I
lumark

Class I

See all devices from Lu Mark Healthcare Co., Ltd. →

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