SAEHAN Corporation
South Korea KR-MF-000024141 Last updated 23 Oct 2026
- Devices
- 28
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
Hand Evaluation Kit, 3pcs with Hard Case (SH5000-3M)) Ref SH5000-3M
Plastic Goniometer Ref SH5201
Plastic Goniometer Ref SH5205
Stainless Steel & Aluminum Goniometer Ref SH5100
Back-Leg-Chest Dynamometer Ref SH5007
Hand Evaluation Kit, 7pcs with Hard Case (SH5000-7) Ref SH5000-7
Plastic Goniometer Ref SH5208
Stainless Steel & Aluminum Goniometer Ref SH5105
Plastic Goniometer Ref SH5202
Squeeze Dynamometer Ref SH5008
Wartenberg Pinwheel Ref SH5114
Plastic Goniometer Ref SH5204
Plastic Goniometer Ref SH5200
Hydraulic Hand Dynamometer Ref SH5001
Plastic Goniometer Ref SH5205-1
Stainless Steel & Aluminum Goniometer Ref SH5104
Skinfold Caliper Ref SH5020
Hydraulic Pinch Gauge Ref SH5005
Mechanical Pinch Gauge Ref SH5005-1
Hand Evaluation Kit, 3pcs with Hard Case (SH5000-3) Ref SH5000-3
Spring Hand Dynamometer Ref SH5002
Stainless Steel & Aluminum Goniometer Ref SH5106
Stainless Steel & Aluminum Goniometer Ref SH5102
Plastic Goniometer Ref SH5203
Stainless Steel & Aluminum Goniometer Ref SH5103
Stainless Steel & Aluminum Goniometer Ref SH5101
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.
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).
Information
- Country
- South Korea
- Address
- 23-29, Bongamgongdan 13-gil, Changwon-si, South Korea
- Website
- www.saehanmedical.com
- [email protected]
- Phone
- +82552940381
- PRRC contact
- Young Tak Jeon
- EUDAMED SRN
- KR-MF-000024141
- FDA FEI number
- 3010581156
- DUNS number
- 689240554