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
Sld	50D-3534	EUDAMED	Class I	Active
Slh	50R-5034	EUDAMED	Class I	Active
32-2006	32-2006	EUDAMED	Class I	Active
22-1225	22-1225	EUDAMED	Class I	Active
Dft	50PT6050	EUDAMED	Class I	Active
Slt	50T-2546	EUDAMED	Class I	Active
Dft	50PM3000	EUDAMED	Class I	Active
Slt	50M-2034	EUDAMED	Class I	Active
Slt	50BL3550	EUDAMED	Class I	Active
Slt	50BL2555	EUDAMED	Class I	Active
Slt	50M-4055	EUDAMED	Class I	Active
Slt	50BL2546	EUDAMED	Class I	Active
Slt	50GS2542	EUDAMED	Class I	Active
Slt	50PP3546	EUDAMED	Class I	Active
Dfk	50P-4000	EUDAMED	Class I	Active
Slt	50T-2550	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572U4046	EUDAMED	Class I	Active
Slh	50R-2542	EUDAMED	Class I	Active
Headlight with Binocular Loupes	556-2542	EUDAMED	Class I	Active
Slt	50BM3546	EUDAMED	Class I	Active
Slt	50BL2555	EUDAMED	Class I	Active
Slh	50R-6042	EUDAMED	Class I	Active
Hl8300	577-0010	EUDAMED	Class I	Active
Hl8200	572-0010	EUDAMED	Class I	Active
Slt	50LG3555	EUDAMED	Class I	Active
Dft	50PT3000	EUDAMED	Class I	Active
Slt	50M-5055	EUDAMED	Class I	Active
Slt	50DB3542	EUDAMED	Class I	Active
Sr24a	418-1112	EUDAMED	Class I	Active
Gl6030	473-1810	EUDAMED	Class I	Active
Slk	50K-2550	EUDAMED	Class I	Active
Slt	50M-6042	EUDAMED	Class I	Active
Slt	50M-2055	EUDAMED	Class I	Active
Slt	50M-3042	EUDAMED	Class I	Active
Slt	50M-2542	EUDAMED	Class I	Active
Hl8200	572-0030	EUDAMED	Class I	Active
Slt	50GM2555	EUDAMED	Class I	Active
Slt	50M-2534	EUDAMED	Class I	Active
Slh	50R-2542	EUDAMED	Class I	Active
Slt	50PP3534	EUDAMED	Class I	Active
Bm800	401E1000	EUDAMED	Class I	Active
22-1217	22-1217	EUDAMED	Class I	Active
Sld	50D-3034	EUDAMED	Class I	Active
Slt	50PP3546	EUDAMED	Class I	Active
Slt	50BS3534	EUDAMED	Class I	Active
Slf	50F-3034	EUDAMED	Class I	Active
Slt	50BS2534	EUDAMED	Class I	Active
Slt	50T-3034	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572U6046	EUDAMED	Class I	Active
Hl8200	572-0080	EUDAMED	Class I	Active

Zumax Medical Co., LTD

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