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lumark
EUDAMEDClass I (EU MDR)
Ref LM-803Ref LM002Model LM-802Ref LM-806Ref LM-908
Identity
- Trade Name
- lumark EUDAMED
- Device Name
- Cold Compression Therapy for Ankle EUDAMEDCold Compression Therapy for Calf EUDAMEDCold Compression Therapy for Thigh EUDAMEDCold Compression Therapy for Spine EUDAMED
- Model / Reference
- LM-803 EUDAMEDLM-802 EUDAMEDLM002 EUDAMEDLM-806 EUDAMEDLM-908 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879060034 EUDAMED04719879060027 EUDAMED04719879060065 EUDAMED04719879060102 EUDAMED
- Basic UDI-DI
- 471987906A003DV EUDAMED471987906A002DT EUDAMED471987906A006E3 EUDAMED471987906A010DS 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
Category: Hot/cold therapy pack, reusable
lumark by Lu Mark Healthcare Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471987906A003DV | 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 (4)
- EUDAMED c9c1c938-70e6-4da9-8dc8-56eb82c650ee 61 fields · synced Jul 30, 2026
- EUDAMED 26416e65-8314-492a-b9fc-a9be3c12232a 61 fields · synced May 18, 2026
- EUDAMED 21914622-d64d-4cf6-813b-f3c2d0d85c57 61 fields · synced May 18, 2026
- EUDAMED bf435001-34c5-4fef-a215-cd7472c3fbed 61 fields · synced May 19, 2026