Identity
- Trade Name
- lumark EUDAMED
- Device Name
- Cold Compression Therapy for Wrist EUDAMED
- Model / Reference
- LM-801 EUDAMEDLM001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879060010 EUDAMED
- Basic UDI-DI
- 471987906A001DR EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
lumark by Lu Mark Healthcare 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 | 471987906A001DR | Class I | Active |
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Manufacturer
- Manufacturer
- Lu Mark Healthcare Co., Ltd.
- EUDAMED SRN
- TW-MF-000015951
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED f94227dd-ffb9-4a8b-a3b0-85851718adab 61 fields · synced Jun 19, 2026