Question 1

What types of medical devices does Premier Guard Zhongshan Ltd. manufacture?

Accepted Answer

Premier Guard Zhongshan Ltd. specializes in manufacturing equipment covers. These covers are designed to protect medical devices and instruments during storage, transport, or cleaning. The products are intended for use with a variety of hospital and clinical equipment, such as surgical instruments, diagnostic devices, and patient monitoring systems.

Question 2

Where is Premier Guard Zhongshan Ltd. based?

Accepted Answer

Premier Guard Zhongshan Ltd. is based in China (CN). The company’s products are developed with a focus on protecting medical equipment, particularly for use in clinical and hospital environments.

Question 3

Which regulatory registries list Premier Guard Zhongshan Ltd.’s devices?

Accepted Answer

Premier Guard Zhongshan Ltd.’s equipment covers are listed in the eudamed database, which is the EU’s central registry for medical devices. This registration reflects compliance with EU requirements for Class I devices, ensuring transparency and traceability for authorized products within the European market.

Question 4

How are Premier Guard Zhongshan Ltd.’s equipment covers classified under medical device regulations?

Accepted Answer

Premier Guard Zhongshan Ltd.’s equipment covers are classified as Class I medical devices. This classification applies because the products are non-invasive, low-risk items intended solely for protecting medical equipment during handling, transport, or cleaning—without altering their function or interacting directly with patients.

Device	Model / Reference	Registries	Class	Status
Equipment Covers	REF11-2103EU	EUDAMED	Class I	Active
Equipment Covers	REF11-2102EU	EUDAMED	Class I	Active
Equipment Covers	14-1660FM	EUDAMED	Class I	Active
Equipment Covers	REF14-1681GEU	EUDAMED	Class I	Active
Equipment Covers	REF10-2104EU	EUDAMED	Class I	Active
Equipment Covers	REF10-1104EU	EUDAMED	Class I	Active
Equipment Covers	REF10-1109EU	EUDAMED	Class I	Active
Equipment Covers	REF10-5197EU	EUDAMED	Class I	Active
Equipment Covers	REF11-2223EU	EUDAMED	Class I	Active
Equipment Covers	10-5194FM	EUDAMED	Class I	Active
Equipment Covers	REF10-2110EU	EUDAMED	Class I	Active
Equipment Covers	11-2112FM	EUDAMED	Class I	Active
Equipment Covers	10-6175FM	EUDAMED	Class I	Active
Equipment Covers	10-2115FM	EUDAMED	Class I	Active
Equipment Covers	REF11-2211EU	EUDAMED	Class I	Active
Equipment Covers	10-1104FM	EUDAMED	Class I	Active
Equipment Covers	REF10-1120EU	EUDAMED	Class I	Active
Equipment Covers	REF10-1101EU	EUDAMED	Class I	Active
Equipment Covers	REF11-2105EU	EUDAMED	Class I	Active
Equipment Covers	REF14-1677EU	EUDAMED	Class I	Active
Equipment Covers	10-1120EU	EUDAMED	Class I	Active
Disposable Surgical Patient Positioning Accessories	14-3103N	EUDAMED	Class I	Active
Equipment Covers	10-4102EU	EUDAMED	Class I	Active
Equipment Covers	10-2185EU	EUDAMED	Class I	Active
Equipment Covers	14-1660EU	EUDAMED	Class I	Active
Equipment Covers	13-1402EU	EUDAMED	Class I	Active
Equipment Covers	11-2224N	EUDAMED	Class I	Active
Equipment Covers	10-2115N	EUDAMED	Class I	Active
Equipment Covers	11-1116EU	EUDAMED	Class I	Active
Equipment Covers	10-5192	EUDAMED	Class I	Active
Equipment Covers	10-5132T	EUDAMED	Class I	Active
Equipment Covers	10-2236EU	EUDAMED	Class I	Active
Equipment Covers	10-2121EU	EUDAMED	Class I	Active
Equipment Covers	11-2112EU	EUDAMED	Class I	Active
Equipment Covers	10-3168APEU	EUDAMED	Class I	Active
Equipment Covers	10-5197EU	EUDAMED	Class I	Active
Equipment Covers	10-3133EU	EUDAMED	Class I	Active
Equipment Covers	10-3165APBAU	EUDAMED	Class I	Active
Equipment Covers	10-3165BAEU	EUDAMED	Class I	Active
Disposable Surgical Patient Positioning Accessories	14-1132NPV	EUDAMED	Class I	Active
Equipment Covers	10-3134APEU	EUDAMED	Class I	Active
Equipment Covers	10-1138N	EUDAMED	Class I	Active
Equipment Covers	11-2211N	EUDAMED	Class I	Active
Disposable Surgical Patient Positioning Accessories	14-5202N	EUDAMED	Class I	Active
Equipment Covers	10-5227TN	EUDAMED	Class I	Active
Equipment Covers	10-1113EU	EUDAMED	Class I	Active
Disposable Surgical Patient Positioning Accessories	14-2101N	EUDAMED	Class I	Active
Equipment Covers	10-3209EU	EUDAMED	Class I	Active
Equipment Covers	10-5183NCS	EUDAMED	Class I	Active
Equipment Covers	10-8110EU	EUDAMED	Class I	Active

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