← Back to catalogue
Azot
EUDAMEDClass I (EU MDR)
Ref AZ-803JLPRef AZ-805XLPModel AZ-1105Ref AZ-908LRef AZ-803JRPRef AZ-11012Ref AZ-806Ref AZ-803SRRef AZ-803JLRef AZ-908XLRef AZ-SCLRef AZ-1701PRef AZ-804Ref AZ-807PRef AZ-11011PRef AZ-11012PRef AZ-805LRef AZ-804PRef AZ-802Ref AZ-803SLRef AZ-805XLRef AZ-87SCLRef AZ-908PRef AZ-802P
Identity
- Trade Name
- AZOT EUDAMED
- Device Name
- Cold Compression Therapy for Ankle Brace EUDAMEDCold Compression Therapy for Knee Ligament Braces EUDAMEDCold Compression Therapy for Spine EUDAMEDCold Compression Therapy for Wrist Brace supports EUDAMEDCold Compression Therapy for Thigh EUDAMEDCold Compression Therapy for Shoulder EUDAMEDCold Compression Therapy for Hallux Valgus splint EUDAMEDCold Compression Therapy for Elbow EUDAMEDCold Compression Therapy for Knee L EUDAMEDCold Compression Therapy for Calf EUDAMED
- Model / Reference
- AZ-803JLP EUDAMEDAZ-1105 EUDAMEDAZ-805XLP EUDAMEDAZ-908L EUDAMEDAZ-803JRP EUDAMEDAZ-11012 EUDAMEDAZ-806 EUDAMEDAZ-803SR EUDAMEDAZ-803JL EUDAMEDAZ-908XL EUDAMEDAZ-SCL EUDAMEDAZ-1701P EUDAMEDAZ-804 EUDAMEDAZ-807P EUDAMEDAZ-11011P EUDAMEDAZ-11012P EUDAMEDAZ-805L EUDAMEDAZ-804P EUDAMEDAZ-802 EUDAMEDAZ-803SL EUDAMEDAZ-805XL EUDAMEDAZ-87SCL EUDAMEDAZ-908P EUDAMEDAZ-802P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879060430 EUDAMED04719879060355 EUDAMED04719879060324 EUDAMED04719879060423 EUDAMED04719879060133 EUDAMED04719879060171 EUDAMED04719879060249 EUDAMED04719879060195 EUDAMED04719879060225 EUDAMED04719879060331 EUDAMED04719879060553 EUDAMED04719879060362 EUDAMED04719879060232 EUDAMED04719879060478 EUDAMED04719879060379 EUDAMED04719879060386 EUDAMED04719879060119 EUDAMED04719879060447 EUDAMED04719879060256 EUDAMED04719879060201 EUDAMED04719879060126 EUDAMED04719879060294 EUDAMED04719879060492 EUDAMED04719879060461 EUDAMED
- Basic UDI-DI
- 471987906A016E6 EUDAMED471987906A012DW EUDAMED471987906A022DZ EUDAMED471987906A014E2 EUDAMED471987906A018EA EUDAMED471987906A020DV EUDAMED471987906A013DY EUDAMED471987906A017E8 EUDAMED471987906A011DU EUDAMED471987906A019EC 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lu Mark Healthcare Co., Ltd.
- EUDAMED SRN
- TW-MF-000015951
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (24)
- EUDAMED a779aabe-5d60-427b-9fd0-f0433ac9bea2 61 fields · synced Jul 29, 2026
- EUDAMED 22dff3ad-3201-4d36-8887-339b009757c2 61 fields · synced May 16, 2026
- EUDAMED be865e42-db7b-42ac-8132-80ee41a2258c 61 fields · synced May 16, 2026
- EUDAMED aac23ffb-9718-4b5d-86db-ab3b8fb60b40 61 fields · synced May 17, 2026
- EUDAMED 2c90568d-b4e2-40cd-8b07-8e11d654dbd4 61 fields · synced May 17, 2026
- EUDAMED cf087997-2ee8-441d-9bb8-df862ece7bf1 61 fields · synced May 17, 2026
- EUDAMED 7fba1ce0-c248-4bbb-ad06-6ea61edb6623 61 fields · synced May 17, 2026
- EUDAMED 76fd73f5-99e4-485f-bb59-e5f12f3390bb 61 fields · synced May 17, 2026
- EUDAMED 7e529242-49b8-427f-94e1-bd32ccf67f40 61 fields · synced May 17, 2026
- EUDAMED ba0913a8-bb23-4cae-b54c-113bfd7e9378 61 fields · synced May 17, 2026
- EUDAMED 6f688a0c-98c0-4ee1-bf5a-671724132380 61 fields · synced May 17, 2026
- EUDAMED e539d309-95d5-4b9b-8a18-1427a01068cf 61 fields · synced May 17, 2026
- EUDAMED 10e65f52-0d73-40aa-9f61-e45d5caecc96 61 fields · synced May 17, 2026
- EUDAMED a676d3ec-5665-491d-90c1-1d29f3cce1d4 61 fields · synced May 18, 2026
- EUDAMED e3873972-ad56-4348-bf2f-640cf65477e4 61 fields · synced May 18, 2026
- EUDAMED 7059fb0c-5bb6-4989-9bb2-092ee5afccf5 61 fields · synced May 18, 2026
- EUDAMED 8f1146ea-3601-40de-8bd7-7a46dbf9a9e5 61 fields · synced May 18, 2026
- EUDAMED ddde2e70-f9bb-4c8d-be6f-fd597a508d6a 61 fields · synced May 18, 2026
- EUDAMED 516c96e7-0688-45a7-b750-4f6579233838 61 fields · synced May 18, 2026
- EUDAMED b54275e1-3dfb-4f68-ab28-5cb1ec2424a7 61 fields · synced May 18, 2026
- EUDAMED d88a4f2e-792a-46b5-9814-8f2b1de5b690 61 fields · synced May 19, 2026
- EUDAMED c9533efb-583c-4ffe-8fad-ee5f9b92a5aa 61 fields · synced May 19, 2026
- EUDAMED 9329d6a9-bc17-4c17-bd3d-c48e27298ab1 61 fields · synced May 19, 2026
- EUDAMED 13bfc63d-5c8f-417e-92d4-fe796517bcf1 61 fields · synced May 19, 2026