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	10-5228STEU	EUDAMED	Class I	Active
Equipment Covers	10-2304EU	EUDAMED	Class I	Active
Equipment Covers	10-1104	EUDAMED	Class I	Active
Equipment Covers	10-2242EU	EUDAMED	Class I	Active
Equipment Covers	10-2104BEU	EUDAMED	Class I	Active
Equipment Covers	10-5282STEU	EUDAMED	Class I	Active
Equipment Covers	10-3163EU	EUDAMED	Class I	Active
Equipment Covers	10-5127TN	EUDAMED	Class I	Active
Equipment Covers	10-3134	EUDAMED	Class I	Active
Equipment Covers	10-1131TEU	EUDAMED	Class I	Active
Equipment Covers	10-5188N	EUDAMED	Class I	Active
Equipment Covers	10-1140	EUDAMED	Class I	Active
Equipment Covers	10-2109EU	EUDAMED	Class I	Active
Equipment Covers	10-2232EU	EUDAMED	Class I	Active
Equipment Covers	10-5189EU	EUDAMED	Class I	Active
Equipment Covers	10-6235	EUDAMED	Class I	Active
Equipment Covers	10-1177N	EUDAMED	Class I	Active
Equipment Covers	10-3166PEU	EUDAMED	Class I	Active
Equipment Covers	10-3132N	EUDAMED	Class I	Active
Equipment Covers	10-5217TN	EUDAMED	Class I	Active
Equipment Covers	11-1139EU	EUDAMED	Class I	Active
Equipment Covers	10-5126TEU	EUDAMED	Class I	Active
Equipment Covers	10-2123EU	EUDAMED	Class I	Active
Equipment Covers	10-3202AP	EUDAMED	Class I	Active
Equipment Covers	11-1101EU	EUDAMED	Class I	Active
Equipment Covers	10-5186EU	EUDAMED	Class I	Active
Equipment Covers	10-3139APEU	EUDAMED	Class I	Active
Equipment Covers	10-3170EU	EUDAMED	Class I	Active
Equipment Covers	11-2104EU	EUDAMED	Class I	Active
Equipment Covers	10-1104EU	EUDAMED	Class I	Active
Equipment Covers	10-3209AEU	EUDAMED	Class I	Active
Equipment Covers	10-2180	EUDAMED	Class I	Active
Equipment Covers	11-2105	EUDAMED	Class I	Active
Fluid collection pouch	17-1122EU	EUDAMED	Class I	Active
Equipment Covers	10-5128TEU	EUDAMED	Class I	Active
Equipment Covers	10-5189N	EUDAMED	Class I	Active
Equipment Covers	10-5198EU	EUDAMED	Class I	Active
Equipment Covers	10-8103EU	EUDAMED	Class I	Active
Equipment Covers	10-1129EU	EUDAMED	Class I	Active
Equipment Covers	11-1203EU	EUDAMED	Class I	Active
Equipment Covers	14-1686EU	EUDAMED	Class I	Active
Equipment Covers	10-5195N	EUDAMED	Class I	Active
Equipment Covers	10-3168BAEU	EUDAMED	Class I	Active
Equipment Covers	10-5208TEU	EUDAMED	Class I	Active
Equipment Covers	10-3135GEU	EUDAMED	Class I	Active
Equipment Covers	10-2160	EUDAMED	Class I	Active
Equipment Covers	10-5184EU	EUDAMED	Class I	Active
Equipment Covers	10-5122TN	EUDAMED	Class I	Active
Equipment Covers	11-3127EU	EUDAMED	Class I	Active
Equipment Covers	10-3134PWEU	EUDAMED	Class I	Active

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