Identity
- Trade Name
- AZOT EUDAMED
- Device Name
- Cold Compression Therapy for Ankle Brace EUDAMED
- Model / Reference
- AZ-803JR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879060218 EUDAMED
- Basic UDI-DI
- 471987906A016E6 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
Azot 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 | 471987906A016E6 | 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 6c9b291f-775a-4dd6-bb39-7197cb7e617b 61 fields · synced Jun 19, 2026