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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 1 of 3

Device	Model / Reference	Registries	Class	Status
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Surgical Series	SUS10	EUDAMEDFDA UDI	Class IIb	Active
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Surgical Series	SUS10	EUDAMEDFDA UDI	Class IIb	Active
Ultrasonic Surgical Series	SUS10	EUDAMEDFDA UDI	Class IIb	Active
ACL Series	X-CUBE	EUDAMED	Class IIa	Active
Traus Series	SIP10	EUDAMEDFDA UDI	Class IIa	Active
TRAUS ENDO Series	TRAUS ENDO	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
Traus Series	SIP10	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Surgical Series	SUS10	EUDAMED	Class IIb	Active
Bone Surgical Engine set	TRT12NOS	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	ACL(B)-03C	EUDAMEDFDA UDI	Class IIa	Active
Air Motor & Air Handpiece & Coupling	CAB10LN	EUDAMEDFDA UDI	Class IIa	Active
TRAUS Series	SAB-R20	EUDAMED	Class IIa	Active
ACL Series	ACL(B)-01C	EUDAMEDFDA UDI	Class IIa	Active
Traus Series	SSG10	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	ACL-41I	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	IM40	EUDAMED	Class IIa	Active
ACL Series	ACL-02C	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	ACL(B)-42I	EUDAMEDFDA UDI	Class IIa	Active
Bone Surgical Engine set	TST10XX	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	E-CUBE	EUDAMEDFDA UDI	Class IIa	Active
Ultrasonic Surgical Series	SP-RS1	EUDAMED	Class IIa	Active
Ultrasonic Surgical Series	SP-028i 4H	EUDAMED	Class IIa	Active
Ultrasonic Surgical Series	SP-016	EUDAMED	Class IIa	Active
Traus SSG30 Surgical System	K232938	FDA 510(k)	Class II	Active
Motor Handpiece and Control Unit (SDI10)	K251407	FDA 510(k)	Class I	Active
STRONG Dental Handpieces	K143418	FDA 510(k)	Class I	Active
Traus Sus10	K151171	FDA 510(k)	Class II	Active
Strong Dental Handpieces	K100192	FDA 510(k)	Class I	Active
Traus Sus20	K192561	FDA 510(k)	Class II	Active
STRONG Dental Handpieces	K171436	FDA 510(k)	Class I	Active
Strong Implant Handpieces	K092412	FDA 510(k)	Class I	Active
Traus SSG10 Surgical System	K233153	FDA 510(k)	Class II	Active
TRAUS Air Dental Handpiece	K221741	FDA 510(k)	Class I	Active
STRONG Dental Handpieces	K181129	FDA 510(k)	Class I	Active
TRAUS Dental Handpieces	K182892	FDA 510(k)	Class I	Active
ACL Series	SURGI CUBE	EUDAMED	Class IIa	Active
ACL Series	ACL(B)-45I	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	X-CUBE	EUDAMEDFDA UDI	Class IIa	Active
Traus Series	CRB27XX	EUDAMED	Class IIa	Active
Air Motor & Air Handpiece & Coupling	ATN400	EUDAMEDFDA UDI	Class IIa	Active
Air Motor & Air Handpiece & Coupling	CAB20ND B2	EUDAMEDFDA UDI	Class IIa	Active
Air Motor & Air Handpiece & Coupling	CAB10LK	EUDAMEDFDA UDI	Class IIa	Active
ACL Series	ACL(B)-03F	EUDAMEDFDA UDI	Class IIa	Active
Traus Series	CRB27LX	EUDAMED	Class IIa	Active
ACL Series	ACL(B)-42EP	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Meridius Medical Europe Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

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

Saeshin Precision Co., Ltd. US