Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

Beijing Allgens Medical Science & Technology Co, L

US

Last updated May 23, 2026

What Beijing Allgens Medical Science & Technology Co, L makes

Beijing Allgens Medical Science & Technology Co., Ltd. manufactures the Bongold bone graft material, a synthetic or composite substance designed for use in orthopedic and maxillofacial surgeries to promote bone regeneration or fill defects.

The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance in the United States. The manufacturer is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Beijing Allgens Medical Science & Technology Co., Ltd. manufacture?

Beijing Allgens Medical Science & Technology Co., Ltd. specializes in the Bongold bone graft material, a synthetic or composite substance. This product is specifically designed for orthopedic and maxillofacial surgeries to aid in bone regeneration or fill bone defects.

Where is Beijing Allgens Medical Science & Technology Co., Ltd. based?

The company is based in the United States. This location is relevant for regulatory compliance, as their devices are subject to U.S. regulatory requirements.

How are the devices manufactured by Beijing Allgens Medical Science & Technology Co., Ltd. classified under U.S. regulations?

The company’s devices, including the Bongold bone graft material, fall under FDA Class II classification. This classification is determined by the risk associated with the device, where Class II devices require special controls in addition to general controls to ensure safety and effectiveness.

Which regulatory registries or databases list the devices produced by Beijing Allgens Medical Science & Technology Co., Ltd.?

The company’s devices, such as the Bongold bone graft material, are listed in the FDA’s 510(k) clearance registry. This registry documents premarket notifications required for Class II devices to demonstrate substantial equivalence to legally marketed predicate devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
—

Catalogue (15)

DeviceModel / ReferenceRegistriesClassStatus
Bongold Bone Graft Material Gr-3
FDA UDI
Class IIActive
Bongold Bone Graft Material Co-3
FDA UDI
Class IIActive
Bongold Bone Graft Material Co-2
FDA UDI
Class IIActive
Bongold Bone Graft Material Re-6
FDA UDI
Class IIActive
Bongold Bone Graft Material Co-4
FDA UDI
Class IIActive
Bongold Bone Graft Material Re-7
FDA UDI
Class IIActive
Bongold Bone Graft Material Re-1
FDA UDI
Class IIActive
Bongold Bone Graft Material Re-5
FDA UDI
Class IIActive
Bongold Bone Graft Material Co-5
FDA UDI
Class IIActive
Bongold Bone Graft Material Co-1
FDA UDI
Class IIActive
Bongold Bone Graft Material Re-2
FDA UDI
Class IIActive
Bongold Bone Graft Material Gr-2
FDA UDI
Class IIActive
Bongold Bone Graft Material Gr-1
FDA UDI
Class IIActive
Bongold Bone Graft Material Re-4
FDA UDI
Class IIActive
Bongold Bone Graft Material K141725
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.