Question 1

What types of medical devices does Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. manufacture?

Accepted Answer

The company specializes in bioabsorbable synthetic polymer devices, specifically extra-gynaecological surgical meshes and nerve guidance conduits. The meshes are designed for soft tissue reinforcement or barrier applications, while the nerve guides support peripheral nerve repair. Both are intended to degrade over time after fulfilling their surgical purpose.

Question 2

Where is Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. based?

Accepted Answer

The company is based in the United States. Its operations and manufacturing align with U.S. medical device regulations, ensuring compliance with applicable frameworks for the devices it produces.

Question 3

Which regulatory registries list the devices manufactured by Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.?

Accepted Answer

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., including those classified under relevant regulatory categories.

Question 4

How are the devices produced by Ningbo Guangyuan Zhixin Biological Technology Co., Ltd. classified under regulatory frameworks?

Accepted Answer

The company’s devices fall under Class II classification. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as those used in surgical reinforcement or nerve repair.

Device	Model / Reference	Registries	Class	Status
SpinMedix® Absorbable Fibrous Membrane	ZK-018	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-017	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-009	FDA UDI	Class II	Active
Rebuilder Nerve Guidance Conduit	TG-050	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-013	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-011	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-002	FDA UDI	Class II	Active
Rebuilder Nerve Guidance Conduit	TG-080	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-012	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-006	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-004	FDA UDI	Class II	Active
Rebuilder Nerve Guidance Conduit	TG-025	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-007	FDA UDI	Class II	Active
Rebuilder Nerve Guidance Conduit	TG-040	FDA UDI	Class II	Active
Rebuilder Nerve Guidance Conduit	TG-070	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-005	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-008	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-003	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-001	FDA UDI	Class II	Active
Rebuilder Nerve Guidance Conduit	TG-060	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-016	FDA UDI	Class II	Active
Rebuilder Nerve Guidance Conduit	TG-100	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-014	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-020	FDA UDI	Class II	Active
Rebuilder Nerve Guidance Conduit	TG-030	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-015	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-019	FDA UDI	Class II	Active
Rebuilder Nerve Guidance Conduit	TG-015	FDA UDI	Class II	Active
Rebuilder Nerve Guidance Conduit	TG-020	FDA UDI	Class II	Active
SpinMedix® Absorbable Fibrous Membrane	ZK-010	FDA UDI	Class II	Active

Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.

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