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
Dft	50PM3000	EUDAMED	Class I	Active
Slt	50BM3542	EUDAMED	Class I	Active
Dm6ge	410E3000	EUDAMED	Class I	Active
Slt	50BM2534	EUDAMED	Class I	Active
Slt	50DB3555	EUDAMED	Class I	Active
Slt	50BS3546	EUDAMED	Class I	Active
Slt	50M-4050	EUDAMED	Class I	Active
Headlight with Binocular Loupes	578-2542	EUDAMED	Class I	Active
Slt	50T-5046	EUDAMED	Class I	Active
Slk	50K-3046	EUDAMED	Class I	Active
Slt	50M-6034	EUDAMED	Class I	Active
Dfk	50PL4000	EUDAMED	Class I	Active
Slt	50T-4046	EUDAMED	Class I	Active
Slh	50R-3046	EUDAMED	Class I	Active
Slt	50T-4034GY-00	EUDAMED	Class I	Active
Slh	50R-2550	EUDAMED	Class I	Active
Dm6c	405-7850	EUDAMED	Class I	Active
DFK air	50P-5000	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572J6046	EUDAMED	Class I	Active
Slt	50BM2555	EUDAMED	Class I	Active
Slt	50T-6042	EUDAMED	Class I	Active
Slt	50M-4042RD-00	EUDAMED	Class I	Active
Slt	50LG3550	EUDAMED	Class I	Active
Headlight with Binocular Loupes	578-3042	EUDAMED	Class I	Active
Slt	50BM3546	EUDAMED	Class I	Active
Slt	50M-6042	EUDAMED	Class I	Active
Dm6u	410-4810	EUDAMED	Class I	Active
Headlight with Binocular Loupes	556-3534	EUDAMED	Class I	Active
Slt	50T-2534	EUDAMED	Class I	Active
Slt	50T-5046	EUDAMED	Class I	Active
Slt	50M-4042	EUDAMED	Class I	Active
Slt	50T-2542	EUDAMED	Class I	Active
Slt	50BL3546	EUDAMED	Class I	Active
Slf	50F-3542	EUDAMED	Class I	Active
Headlight with Binocular Loupes	556-3050	EUDAMED	Class I	Active
Dfk	50P-3000	EUDAMED	Class I	Active
Slf	50F-2542	EUDAMED	Class I	Active
Sr24a	418-5812	EUDAMED	Class I	Active
Sle	50E-3046	EUDAMED	Class I	Active
22-1021	22-1021	EUDAMED	Class I	Active
Slt	50BS3555	EUDAMED	Class I	Active
Slt	50M-5046	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572U4050	EUDAMED	Class I	Active
Slt	50T-5034	EUDAMED	Class I	Active
Slh	50RJ3542	EUDAMED	Class I	Active
Slt	50GM2546	EUDAMED	Class I	Active
Slh	50R-3042	EUDAMED	Class I	Active
Headlight with Binocular Loupes	555-3034	EUDAMED	Class I	Active
Slf	50F-2534	EUDAMED	Class I	Active
10-0025	10-0025	EUDAMED	Class I	Active

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