Question 1

What types of medical devices does HI-LIFE Technology (Hebei) Co., Ltd primarily manufacture?

Accepted Answer

HI-LIFE Technology (Hebei) Co., Ltd specializes in basic electric hospital beds, which include examination couches, operating tables, and electric operating tables. They also produce reusable device sterilization/disinfection containers, hospital trolleys, and surgical lithotomy stirrup leg holders. These products are designed for clinical environments to support patient care and procedural needs.

Question 2

Where is HI-LIFE Technology (Hebei) Co., Ltd based?

Accepted Answer

The company is headquartered in China. This geographic location influences its regulatory compliance framework, though individual devices must meet the specific requirements of the markets they are intended for, such as the EU’s medical device regulations.

Question 3

Which regulatory registries list devices manufactured by HI-LIFE Technology (Hebei) Co., Ltd?

Accepted Answer

Devices from HI-LIFE Technology (Hebei) Co., Ltd are listed in the eudamed registry, which is the European database for medical devices. This registry is used to track devices authorized for sale within the European Union, ensuring transparency and traceability.

Question 4

How are the medical devices produced by HI-LIFE Technology (Hebei) Co., Ltd classified?

Accepted Answer

The company’s devices fall under Class I classification. This classification is typically assigned to low-risk medical devices, such as basic hospital beds and reusable sterilization containers, which pose minimal risk to patients and users when used as intended.

Device	Model / Reference	Registries	Class	Status
Electric Hospital Bed	EHDB21	EUDAMED	Class I	Active
Examination Couch	ECA16	EUDAMED	Class I	Active
Hospital Trolley	HTA41	EUDAMED	Class I	Active
Examination Couch	ECA16	EUDAMED	Class I	Active
Operating Table	OTA31	EUDAMED	Class I	Active
Electric Operating Table	EOTB33	EUDAMED	Class I	Active
Hospital Bed	HBA14	EUDAMED	Class I	Active
Hospital Bed	HBA12	EUDAMED	Class I	Active
Electric Operating Table	EOTB22	EUDAMED	Class I	Active
Hospital Bed	HBA13	EUDAMED	Class I	Active
Surgical Lithotomy stirrup Leg Holders	LHA110	EUDAMED	Class I	Active
Electric Hospital Bed	EHDB21	EUDAMED	Class I	Active
Surgical Positioning Pad	SPPA81	EUDAMED	Class I	Active
Delivery Bed	DBA23	EUDAMED	Class I	Active
Electric Operating Table	EOTB34	EUDAMED	Class I	Active
Patient Return Electrode Pad	EPB120	EUDAMED	Class I	Active
Examination Couch	ECA16	EUDAMED	Class I	Active
Electric Operating Table	EOTB22	EUDAMED	Class I	Active
Electric Hospital Bed	EHDB11	EUDAMED	Class I	Active
Hospital Bed	HBA13	EUDAMED	Class I	Active
Hospital Trolley	HTA41	EUDAMED	Class I	Active
Hospital Bed	HBA15	EUDAMED	Class I	Active
Electric Operating Table	EOTB32	EUDAMED	Class I	Active

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