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SAESHIN PRECISION CO.,LTD.

South Korea·KR-MF-000016345

Last updated June 8, 2026

About

In the bottom of control box, there is QR code for scanning. This can be tracked at our website to check the authenticity. The scan is available 5 times only and for further check of authenticity, please contact your nearest located Saeshin's authorized dealer or Saeshin office

From the manufacturer's own website. Source

Information

Country: South Korea
Address: 52, secheon-ro 1, daegu, South Korea
Website: www.saeshin.com/
LinkedIn: —
Facebook: facebook.com/saeshin.traus/photos
Email: [email protected]
Phone: 82 52 587 0918
PRRC Contact: San Nam-Gung
EUDAMED SRN: KR-MF-000016345
FDA FEI Number: —
DUNS Number: —

Catalogue (138)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
ACL Series	E-CUBE	EUDAMEDFDA UDI	Class IIa	Active
Bone Surgical Engine set	CRT14XX	EUDAMEDFDA UDI	Class IIa	Active
Traus Series	CRB46LN	EUDAMEDFDA UDI	Class IIa	Active
TRAUS ENDO Series	Dia-Gear Handpiece	EUDAMED	Class IIa	Active
Traus Series	XIP10	EUDAMEDFDA UDI	Class IIa	Active
Air Motor & Air Handpiece & Coupling	CAB20ND M4	EUDAMEDFDA UDI	Class IIa	Active
Air Motor & Air Handpiece & Coupling	CAB10LN	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Surgical Series	XUS10	EUDAMEDFDA UDI	Class IIb	Active
TRAUS ENDO Series	ACL(B)-41EP	EUDAMEDFDA UDI	Class IIa	Active
Traus Series	MBP10SL	EUDAMED	Class IIa	Active
Ultrasonic Surgical Series	SP-BT2	EUDAMED	Class IIa	Active
Ultrasonic Surgical Series	SUS10	EUDAMEDFDA UDI	Class IIb	Active
TRAUS ENDO Series	Dia-Gear Angle	EUDAMED	Class IIa	Active
Bone Surgical Engine set	TRT12NSG	EUDAMEDFDA UDI	Class IIa	Active
Air Motor & Air Handpiece & Coupling	MRD22NN	EUDAMED	Class IIa	Active
ACL Series	ACL(B)-04C	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	BIP10E	EUDAMED	Class IIa	Active
TRAUS Series	SAB-S6	EUDAMED	Class IIa	Active
ACL Series	AT-I	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Surgical Series	SUS20	EUDAMEDFDA UDI	Class IIb	Active
Ultrasonic Surgical Series	SUS10	EUDAMED	Class IIb	Active
Ultrasonic Surgical Series	SP-100	EUDAMED	Class IIa	Active
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
TRAUS ENDO Series	XEW10	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	E-CUBE	EUDAMEDFDA UDI	Class IIa	Active
Bone Surgical Engine set	TRT12NSH	EUDAMED	Class IIa	Active
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	ACL-01C	EUDAMEDFDA UDI	Class IIa	Active
TRAUS Series	SAB-O8	EUDAMED	Class IIa	Active
ACL Series	CUBE EP	EUDAMEDFDA UDI	Class IIa	Active
TRAUS ENDO Series	BA182511	EUDAMED	Class IIa	Active
TRAUS ENDO Series	BAE05	EUDAMED	Class IIa	Active
Air Motor & Air Handpiece	MRD22NN/ACL(B)-01C/AT-II/CAB20NDM4	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
TRAUS ENDO Series	Optima E+BAE370R	EUDAMED	Class IIa	Active
TRAUS ENDO Series	BAE03	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Meridius Medical Europe Limited IE

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Saeshin Precision Co., Ltd. US