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	50T-6050	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572-3050	EUDAMED	Class I	Active
Dfk	50P-3000	EUDAMED	Class I	Active
Bm800	401E1020	EUDAMED	Class I	Active
Slf	50FJ3542	EUDAMED	Class I	Active
Sle	50E-3550	EUDAMED	Class I	Active
Slf	50F-3534	EUDAMED	Class I	Active
Slt	50BS3550	EUDAMED	Class I	Active
Hl8000	556-0080	EUDAMED	Class I	Active
Slt	50M-3046	EUDAMED	Class I	Active
Slt	50T-2042	EUDAMED	Class I	Active
Slt	50M-2542	EUDAMED	Class I	Active
Dft	50PT3040	EUDAMED	Class I	Active
Slt	50T-5050	EUDAMED	Class I	Active
Slt	50BS2550	EUDAMED	Class I	Active
Sls	50S-3046	EUDAMED	Class I	Active
Sr24a	418-4812	EUDAMED	Class I	Active
Slt	50BL3534	EUDAMED	Class I	Active
Slt	50LG3550	EUDAMED	Class I	Active
DFK air	50PL4000	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572J4050	EUDAMED	Class I	Active
Slh	50R-6034	EUDAMED	Class I	Active
Slt	50BM2546	EUDAMED	Class I	Active
Slt	50M-5050	EUDAMED	Class I	Active
Slt	50M-5046	EUDAMED	Class I	Active
Slk	50K-3534	EUDAMED	Class I	Active
Slt	50M-6055	EUDAMED	Class I	Active
Slt	50BM3534	EUDAMED	Class I	Active
Headlight with Binocular Loupes	572J5042	EUDAMED	Class I	Active
Hl8200	570-0070	EUDAMED	Class I	Active
Headlight with Binocular Loupes	556-2534	EUDAMED	Class I	Active
Dfk	50PL3040	EUDAMED	Class I	Active
Sr24g	418-3002	EUDAMED	Class I	Active
Hl8260	572-8280	EUDAMED	Class I	Active
Headlight with Binocular Loupes	550-2542	EUDAMED	Class I	Active
Slt	50GL2542	EUDAMED	Class I	Active
Slh	50RJ3042	EUDAMED	Class I	Active
Slt	50BS2534	EUDAMED	Class I	Active
Dft	50PT5040	EUDAMED	Class I	Active
Dm6d	410-5820	EUDAMED	Class I	Active
Slt	50GL2546	EUDAMED	Class I	Active
Gl6040	474-1810	EUDAMED	Class I	Active
Slh	50R-2546	EUDAMED	Class I	Active
Slf	50F-2534	EUDAMED	Class I	Active
Headlight with Binocular Loupes	556-3034	EUDAMED	Class I	Active
Slt	50M-4034	EUDAMED	Class I	Active
Dft	50PT4055	EUDAMED	Class I	Active
Slt	50GM2534	EUDAMED	Class I	Active
Gl6020	472-1810	EUDAMED	Class I	Active
Slt	50GS2550	EUDAMED	Class I	Active

Zumax Medical Co., LTD

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