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Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd

China·CN-MF-000025423

Last updated May 23, 2026

What Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd makes

The company designs and manufactures stationary diagnostic x-ray system generators, which provide high-voltage power for medical imaging equipment. It also produces x-ray tube housing assemblies, which house and protect the x-ray tube components used in diagnostic imaging systems.

These devices are classified as Class I and Class IIb under regulatory frameworks, with listings in the EU’s EUDAMED database and the FDA’s UDI system. The company is based in Suzhou Industrial Park, China.

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 Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd primarily manufacture?

Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd specializes in designing and manufacturing stationary diagnostic x-ray system generators and x-ray tube housing assemblies. These devices are critical components for medical imaging systems, with generators providing high-voltage power and tube housing assemblies protecting and housing the x-ray tube components.

Where is Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd based?

The company is headquartered in Suzhou Industrial Park, China. This location serves as its primary operational base for developing and producing its medical imaging-related devices.

Which regulatory databases list devices manufactured by Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd?

Devices from Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd are listed in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. These registries help track and monitor medical devices under regulatory oversight in the European Union and the United States.

How are the devices produced by Spellman High Voltage Electronics(Suzhou Industrial Park) Co., Ltd classified under regulatory frameworks?

The company’s devices are classified as either Class I or Class IIb. This classification is determined by factors such as the risk associated with the device’s use, with Class IIb indicating a higher risk level that requires stricter regulatory controls compared to Class I.

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

Information

Country: China
Address: 86, Jinjiang Road, Suzhou, China
Website: -
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: -
PRRC Contact: Sherry Zhang
EUDAMED SRN: CN-MF-000025423
FDA FEI Number: —
DUNS Number: 529124841

Catalogue (38)

Device	Model / Reference	Registries	Class	Status
S Spellman High Voltage Electronics Corporation	ZR75PN80	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN32	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN32S	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN65	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN50	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	409085-002	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN40S	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN32S	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN40	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN40S	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN50	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN40	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN65	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN32	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN50	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN40	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	409085-001	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	409085-007	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN80	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN32S	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN32	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN80	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN40S	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN32S	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN65	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN65	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN50	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN32	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN40	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN40S	FDA UDI	Class I	Active
S Spellman High Voltage Electronics Corporation	ZR75PN80	FDA UDI	Class I	Active
Radiography X-Ray High Voltage Generator used in X-Ray Imaging System	ZR75PN32S	EUDAMEDFDA UDI	Class IIb	Active
Radiography X-Ray High Voltage Generator used in X-Ray Imaging System	ZR75PN40	EUDAMEDFDA UDI	Class IIb	Active
Radiography X-Ray High Voltage Generator used in X-Ray Imaging System	ZR75PN65	EUDAMEDFDA UDI	Class IIb	Active
Radiography X-Ray High Voltage Generator used in X-Ray Imaging System	ZR75PN32	EUDAMEDFDA UDI	Class IIb	Active
Radiography X-Ray High Voltage Generator used in X-Ray Imaging System	ZR75PN80	EUDAMEDFDA UDI	Class IIb	Active
Radiography X-Ray High Voltage Generator used in X-Ray Imaging System	ZR75PN40S	EUDAMEDFDA UDI	Class IIb	Active
Radiography X-Ray High Voltage Generator used in X-Ray Imaging System	ZR75PN50	EUDAMEDFDA UDI	Class IIb	Active

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