Question 1

What types of medical devices does Shandong Zhenfu Medical Device Co., Ltd. manufacture?

Accepted Answer

Shandong Zhenfu Medical Device Co., Ltd. specializes in respiratory and surgical filtration products. Their portfolio includes suction filters, bacterial and viral filters, heat and moisture exchange (HME) filters, tracheostomy HME filters, essential insufflation filter/tubing sets with Luer Lock, oxygen concentrator filters, and smoke filters with integrated tubing. These devices are designed to improve safety and efficiency in medical procedures by filtering contaminants and moisture.

Question 2

Where is Shandong Zhenfu Medical Device Co., Ltd. based?

Accepted Answer

The company is based in China. While the specific location within the country is not detailed, its regulatory filings and device classifications align with Chinese medical device manufacturing standards and global compliance requirements.

Question 3

Which regulatory registries list Shandong Zhenfu Medical Device Co., Ltd.’s devices?

Accepted Answer

Shandong Zhenfu Medical Device Co., Ltd.’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This inclusion indicates compliance with EU regulatory requirements for devices classified under Class I and Class IIa, ensuring transparency and traceability for authorized products.

Question 4

How are Shandong Zhenfu Medical Device Co., Ltd.’s devices classified under EU regulations?

Accepted Answer

Under EU medical device regulations, Shandong Zhenfu Medical Device Co., Ltd.’s devices fall into Class I and Class IIa categories. This classification is determined by factors like the device’s intended use, risk level, and potential health impact. For example, filters like bacterial-viral filters or HME filters are typically classified as Class IIa due to their role in preventing infections or maintaining sterile conditions, while simpler suction filters may qualify as Class I.

Device	Model / Reference	Registries	Class	Status
suction filter	ZF-014	EUDAMED	Class I	Active
Bacterial viral filter	ZF-053	EUDAMED	Class I	Active
Heat and moisture exchange filter	ZF-218	EUDAMED	Class I	Active
Bacterial viral filter	703	EUDAMED	Class I	Active
Heat and moisture exchange filter	ZF-233	EUDAMED	Class IIa	Active
Bacterial viral filter	ZF-019	EUDAMED	Class I	Active
Essential Insufflation Filter/Tubing Set with Luer Lock	PS3600A	EUDAMED	Class IIa	Active
Heat and moisture exchange filter	ZF-233	EUDAMED	Class I	Active
Tracheostomy HME filter	ZF-302	EUDAMED	Class IIa	Active
Bacterial-viral filter	ZF-053	EUDAMED	Class IIa	Active
oxygen concentrator filter	ZF-055	EUDAMED	Class I	Active
Smoke filter with tube	752	EUDAMED	Class I	Active
Essential Insufflation Filter/Tubing Set with O Ring Connector	PS3601A	EUDAMED	Class IIa	Active
Disposable HME breathing filter	607	EUDAMED	Class I	Active
membrane filter	716	EUDAMED	Class I	Active
Bacterial-viral filter	7009	EUDAMED	Class I	Active
Bacterial viral filter	717	EUDAMED	Class I	Active
HME filter	615	EUDAMED	Class I	Active
oxygen concentrator filter	ZF-111	EUDAMED	Class IIa	Active
Bacterial viral filter	ZF-222	EUDAMED	Class I	Active
Heat and moisture exchange filter	ZF-219	EUDAMED	Class I	Active
Bacterial-viral filter	ZF-074	EUDAMED	Class IIa	Active
Bacterial-viral filter	710	EUDAMED	Class I	Active
precision Iiquid filter	ZF-286	EUDAMED	Class I	Active
Bacterial viral filter	715	EUDAMED	Class I	Active
Heat and moisture exchange filter	ZF-001	EUDAMED	Class I	Active
Heat and moisture exchange filter	ZF-113	EUDAMED	Class I	Active
Disposable HMEF breathing filter	605	EUDAMED	Class I	Active
Essential Smoke Filter	PS3604A	EUDAMED	Class I	Active
Essential Insufflation Filter/Tubing Set with Push Fit Funnel Connector	PS3602A	EUDAMED	Class IIa	Active
Bacterial viral filter	712	EUDAMED	Class I	Active
Heat and moisture exchange filter	ZF-001	EUDAMED	Class IIa	Active
Bacterial viral filter	ZF-063	EUDAMED	Class I	Active
Essential Insufflation Filter/Tubing Set with 15mm/22mm Connector	PS3605A	EUDAMED	Class IIa	Active
HME filter	613	EUDAMED	Class I	Active
Bacterial viral filter	713	EUDAMED	Class I	Active
Bacterial/viral filter	707	EUDAMED	Class I	Active
Essential Insufflation Filter/Tubing Set with 15mm Connector	PS3603A	EUDAMED	Class IIa	Active
Disposable HEPA breathing filter	608	EUDAMED	Class I	Active
smoke filter	/	EUDAMED	Class IIa	Active

SHANDONG ZHENFU MEDICAL DEVICE CO., LTD.

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