Question 1

What types of medical devices does Zumax Medical Co., Ltd. manufacture?

Accepted Answer

Zumax Medical Co., Ltd. specializes in ophthalmic surgical instruments. Their product range includes headlights with binocular loupes, which provide enhanced illumination and magnification for surgeons during eye procedures. They also produce slit-lamp attachments (such as SLT, SLH, and SLS) designed for detailed eye examinations, as well as diagnostic tools like the DFT, which appears to focus on imaging or measuring the anterior segment of the eye.

Question 2

Where is Zumax Medical Co., Ltd. based?

Accepted Answer

Zumax Medical Co., Ltd. is headquartered in China. The company’s location influences its regulatory compliance, particularly for markets like the EU, where devices must meet specific standards and documentation requirements.

Question 3

Which regulatory registries list Zumax Medical Co., Ltd.’s devices?

Accepted Answer

Zumax Medical Co., Ltd.’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry tracks devices that have undergone the necessary conformity assessment procedures to comply with EU regulations, such as CE marking for Class I devices.

Question 4

How are Zumax Medical Co., Ltd.’s devices classified under EU regulations?

Accepted Answer

Zumax Medical Co., Ltd.’s devices are classified as Class I medical devices under EU regulations. This classification applies to low-risk products like many ophthalmic surgical instruments and diagnostic tools, which typically require less stringent regulatory oversight compared to higher-risk classes. Classification determines the documentation and conformity assessment steps required before a device can be placed on the market.

Device	Model / Reference	Registries	Class	Status
Slt	50PP3555	EUDAMED	Class I	Active
Hl8200	572-0060	EUDAMED	Class I	Active
Slt	50BL2550	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572U6042	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572-6042	EUDAMED	Class I	Active
Slt	50M-5055	EUDAMED	Class I	Active
Slk	50S-2546	EUDAMED	Class I	Active
Slh	50R-3546	EUDAMED	Class I	Active
Slk	50S-2534	EUDAMED	Class I	Active
Sle	50E-2550	EUDAMED	Class I	Active
Slt	50T-2546	EUDAMED	Class I	Active
Sle	50E-2534	EUDAMED	Class I	Active
Slt	50M-6046	EUDAMED	Class I	Active
Slt	50M-4055	EUDAMED	Class I	Active
Dft	50PT6055	EUDAMED	Class I	Active
Slt	50LG3555	EUDAMED	Class I	Active
Slt	50M-2546	EUDAMED	Class I	Active
22-0817	22-0817	EUDAMED	Class I	Active
Slt	50T-5046	EUDAMED	Class I	Active
Slf	50F-3046	EUDAMED	Class I	Active
Slt	50BL3546	EUDAMED	Class I	Active
Slt	50T-5050	EUDAMED	Class I	Active
Dfk	50PL5000	EUDAMED	Class I	Active
Hl8300	578-0080	EUDAMED	Class I	Active
Slk	50K-3042	EUDAMED	Class I	Active
Slt	50LG3546	EUDAMED	Class I	Active
Slt	50T-2542	EUDAMED	Class I	Active
Dm6g	410-3000	EUDAMED	Class I	Active
Slt	50GS2534	EUDAMED	Class I	Active
Headlight with Binocular Loupes	556-3546	EUDAMED	Class I	Active
Slt	50LG3542	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572-4046	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572-4050	EUDAMED	Class I	Active
Sle	50E-3546	EUDAMED	Class I	Active
Slt	50T-3046	EUDAMED	Class I	Active
Slt	50BL2546	EUDAMED	Class I	Active
DFK air	50PL4000	EUDAMED	Class I	Active
Slt	50M-2550	EUDAMED	Class I	Active
Slt	50T-6034	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572-2546	EUDAMED	Class I	Active
Hl8300	576-0040	EUDAMED	Class I	Active
Slt	50T-3046	EUDAMED	Class I	Active
Slt	50BS3550	EUDAMED	Class I	Active
Slh	50R-5042	EUDAMED	Class I	Active
Slt	50M-6055	EUDAMED	Class I	Active
Slt	50M-2542	EUDAMED	Class I	Active
Slt	50T-2546	EUDAMED	Class I	Active
Slf	50F-2546	EUDAMED	Class I	Active
Dfk	50PL4000	EUDAMED	Class I	Active
Slh	50R-3542	EUDAMED	Class I	Active

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