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	10-5227TNCS	EUDAMED	Class I	Active
Equipment Covers	11-1221GMT	EUDAMED	Class I	Active
Equipment Covers	10-3209A	EUDAMED	Class I	Active
Equipment Covers	10-2241EU	EUDAMED	Class I	Active
Equipment Covers	10-5206TEU	EUDAMED	Class I	Active
Disposable Surgical Patient Positioning Accessories	14-1120N	EUDAMED	Class I	Active
Equipment Covers	10-5182EU	EUDAMED	Class I	Active
Equipment Covers	10-2106	EUDAMED	Class I	Active
Equipment Covers	10-2175EU	EUDAMED	Class I	Active
Equipment Covers	10-6219EU	EUDAMED	Class I	Active
Equipment Covers	10-3105EU	EUDAMED	Class I	Active
Equipment Covers	10-5234EU	EUDAMED	Class I	Active
Disposable Surgical Patient Positioning Accessories	50-2061	EUDAMED	Class I	Active
Equipment Covers	10-6105EU	EUDAMED	Class I	Active
Equipment Covers	10-8145	EUDAMED	Class I	Active
Equipment Covers	11-2204NKT	EUDAMED	Class I	Active
Equipment Covers	10-3165AUL	EUDAMED	Class I	Active
Equipment Covers	10-3167AP	EUDAMED	Class I	Active
Equipment Covers	10-3162N	EUDAMED	Class I	Active
Equipment Covers	10-3138PEU	EUDAMED	Class I	Active
Equipment Covers	10-6184EU	EUDAMED	Class I	Active
Equipment Covers	10-2180EU	EUDAMED	Class I	Active
Equipment Covers	10-3136APEU	EUDAMED	Class I	Active
Equipment Covers	10-3167PEU	EUDAMED	Class I	Active
Equipment Covers	10-5129TEU	EUDAMED	Class I	Active
Equipment Covers	10-2130EU	EUDAMED	Class I	Active
Equipment Covers	10-1111NKT	EUDAMED	Class I	Active
Equipment Covers	10-2178EU	EUDAMED	Class I	Active
Equipment Covers	10-8145N	EUDAMED	Class I	Active
Equipment Covers	10-2115	EUDAMED	Class I	Active
Equipment Covers	10-4104EU	EUDAMED	Class I	Active
Equipment Covers	10-1137EU	EUDAMED	Class I	Active
Equipment Covers	11-2205N	EUDAMED	Class I	Active
Equipment Covers	10-3135PEU	EUDAMED	Class I	Active
Equipment Covers	10-2205EU	EUDAMED	Class I	Active
Equipment Covers	10-5140TN	EUDAMED	Class I	Active
Equipment Covers	10-3165AEU	EUDAMED	Class I	Active
Equipment Covers	10-2302EU	EUDAMED	Class I	Active
Equipment Covers	11-1218EU	EUDAMED	Class I	Active
Equipment Covers	10-4108N	EUDAMED	Class I	Active
Equipment Covers	10-1111EU	EUDAMED	Class I	Active
Equipment Covers	10-3167AGEU	EUDAMED	Class I	Active
Equipment Covers	10-2135EU	EUDAMED	Class I	Active
Equipment Covers	10-5189NCS	EUDAMED	Class I	Active
Equipment Covers	11-1213EU	EUDAMED	Class I	Active
Disposable Surgical Patient Positioning Accessories	14-1145NE	EUDAMED	Class I	Active
Equipment Covers	14-1676EU	EUDAMED	Class I	Active
Equipment Covers	10-3142EU	EUDAMED	Class I	Active
Equipment Covers	10-7113	EUDAMED	Class I	Active
Equipment Covers	10-1138EU	EUDAMED	Class I	Active

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