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SAEHAN Corporation

South Korea KR-MF-000024141 Last updated 23 Oct 2026

Devices
28
Registries
EUDAMEDGUDIDFDA
FDA recalls
0

Catalogue28

What SAEHAN Corporation makes

SAEHAN Corporation manufactures rehabilitation and physical therapy assessment tools, including dynamometers for measuring muscle strength (back, leg, chest, and hand), goniometers for joint range-of-motion testing, and evaluation kits for hand function testing. Their products also include a squeeze dynamometer for grip strength assessment and a Wartenberg pinwheel for sensory evaluation.

All listed devices fall under Class I per EU regulations and are registered in the eudamed database. The company is based in South Korea.

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 SAEHAN Corporation manufacture?

SAEHAN Corporation specializes in rehabilitation and physical therapy assessment tools. Their product range includes dynamometers—such as back, leg, chest, and hand dynamometers—for measuring muscle strength, goniometers (plastic and stainless steel/aluminum) for evaluating joint range-of-motion, and specialized kits like the Hand Evaluation Kit for assessing hand function. They also produce devices like a squeeze dynamometer for grip strength and a Wartenberg pinwheel for sensory testing.

Where is SAEHAN Corporation based?

SAEHAN Corporation is headquartered in South Korea. This location reflects their regional focus on manufacturing and supplying rehabilitation assessment tools, though their devices may be used globally.

Which regulatory registries list SAEHAN Corporation’s devices?

SAEHAN Corporation’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This registration is required for Class I devices marketed within the European Economic Area.

How are SAEHAN Corporation’s devices classified under EU regulations?

All of SAEHAN Corporation’s listed devices fall under Class I classification in the EU. This classification applies to low-risk devices like assessment tools (e.g., dynamometers, goniometers) that pose minimal risk to patients when used as intended. Class I devices require less stringent regulatory oversight but still must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD).

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

Information

Country
South Korea
Address
23-29, Bongamgongdan 13-gil, Changwon-si, South Korea
Phone
+82552940381
PRRC contact
Young Tak Jeon
EUDAMED SRN
KR-MF-000024141
FDA FEI number
3010581156
DUNS number
689240554