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Sign in to claim this brandLu Mark Healthcare Co., Ltd.
Taiwan·TW-MF-000015951
Last updated September 18, 2026
About
Established in 1992, Lumark Enterprises Inc. is a reliable manufacturer of patented products such as Cold Compression Therapy Series, Ice Wrap Series, Medical Cuffs, Ice & Warm Water Bags, Hot & Cold Gel Pack, Water Circulation Machines, Wine Cooler, and more. Our R&D center and factory are situated in Taiwan. At Lumark Enterprises Inc., we are committed to deliver the best products and services to our clients. We continuously strive to innovate and improve our offerings, ensuring that our customers receive the utmost satisfaction from us. Our products are marketed worldwide and are highly regarded for their good quality, performance, and reliability. We can turn your product ideas into high quality products you can hold. Choose Lumark Enterprises Inc. for your product needs, and experience the difference that excellence makes.
From the manufacturer's own website. Source
What Lu Mark Healthcare Co., Ltd. makes
Lu Mark Healthcare Co., Ltd. manufactures AZOT-branded cold compression therapy devices, including ice wraps, medical cuffs, ice and warm water bags, hot/cold gel packs, and water circulation machines.
These products are classified as Class I medical devices and are listed in the EU’s eudamed registry. The company is based in Taiwan.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Lu Mark Healthcare Co., Ltd. manufacture?
Lu Mark Healthcare Co., Ltd. specializes in AZOT-branded cold compression therapy devices. These include ice wraps, medical cuffs, ice and warm water bags, hot and cold gel packs, and water circulation machines. The company focuses on products designed to provide therapeutic cold or warm compression for medical and recovery applications.
Where is Lu Mark Healthcare Co., Ltd. based, and where are its products manufactured?
Lu Mark Healthcare Co., Ltd. is based in Taiwan, where its research and development center and factory are located. The company’s manufacturing facilities are situated in Taiwan, ensuring production and quality control are handled in-house.
Which regulatory registries list Lu Mark Healthcare Co., Ltd.’s devices?
Lu Mark Healthcare Co., Ltd.’s devices are listed in the EU’s eudamed registry. This registry is used to track medical devices authorized for commercialization within the European Economic Area, ensuring transparency and compliance with EU medical device regulations.
How are Lu Mark Healthcare Co., Ltd.’s devices classified under medical device regulations?
Lu Mark Healthcare Co., Ltd.’s devices are classified as Class I medical devices. This classification typically applies to low-risk products, such as cold compression therapy items, which pose minimal risk to patients when used as intended. Class I devices generally require less stringent regulatory oversight compared to higher-risk categories.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Taiwan
- Address
- No.255, Sec.2, Zhongshan E.Rd., Xinwu Dist, Taoyuan, Taiwan
- Website
- www.lumarks.com
- —
- —
- [email protected]
- Phone
- +886 3-4773355
- PRRC Contact
- Mark Lu
- EUDAMED SRN
- TW-MF-000015951
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (29)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| lumark | LM-805 | EUDAMED | Class I | Active |
| Azot | AZ-803JR | EUDAMED | Class I | Active |
| Azot | AZ-SCS | EUDAMED | Class I | Active |
| Azot | AZ-803P | EUDAMED | Class I | Active |
| Azot | AZ-83SPT | EUDAMED | Class I | Active |
| Azot | AZ-11011 | EUDAMED | Class I | Active |
| Azot | AZ-810P | EUDAMED | Class I | Active |
| Azot | AZ-807 | EUDAMED | Class I | Active |
| Azot | AZ-805LP | EUDAMED | Class I | Active |
| Azot | AZ-87SCS | EUDAMED | Class I | Active |
| Azot | AZ-83SPR | EUDAMED | Class I | Active |
| Azot | AZ-1105XL | EUDAMED | Class I | Active |
| lumark | LM-807 | EUDAMED | Class I | Active |
| Azot | AZ-802XP | EUDAMED | Class I | Active |
| Azot | AZ-810 | EUDAMED | Class I | Active |
| Azot | AZ-803 | EUDAMED | Class I | Active |
| Azot | AZ-SCM | EUDAMED | Class I | Active |
| Azot | AZ-87SCM | EUDAMED | Class I | Active |
| lumark | LM-804 | EUDAMED | Class I | Active |
| lumark | LM-810 | EUDAMED | Class I | Active |
| Azot | AZ-83ACP | EUDAMED | Class I | Active |
| lumark | LM001 | EUDAMED | Class I | Active |
| Azot | AZ-1701 | EUDAMED | Class I | Active |
| lumark | LM-808 | EUDAMED | Class I | Active |
| Azot | AZ-806P | EUDAMED | Class I | Active |
| Azot | AZ-805LH | EUDAMED | Class I | Active |
| lumark | LM-803 | EUDAMED | Class I | Active |
| Azot | AZ-908M | EUDAMED | Class I | Active |
| Azot | AZ-803JLP | EUDAMED | Class I | Active |
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