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ASTAR ORTHODONTICS INC.

China·CN-MF-000028647

Last updated September 17, 2026

Information

Country: China
Address: South Zhongshan Road Section 1, Shanghai, China
Website: astar-ortho.com.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: WENJIE HE
EUDAMED SRN: CN-MF-000028647
FDA FEI Number: 3004704962
DUNS Number: —

Catalogue (2607)

Page 52 of 53

Device	Model / Reference	Registries	Class	Status
Sandon	3331-1028	EUDAMED	Class IIa	Active
Gleaming	1433-043Hd	EUDAMED	Class IIa	Active
Easter	HT1832-041	EUDAMED	Class IIa	Active
Rato	1531-044Hm	EUDAMED	Class IIa	Active
Oppa	1852-025Hd	EUDAMED	Class IIa	Active
Kola	3321-3143	EUDAMED	Class IIa	Active
Orthodontic Archwires	6121-1925-HS	EUDAMED	Class IIa	Active
Orthodontic Lingual Retainer	4401-38	EUDAMED	Class IIa	Active
Thino	1264-011	EUDAMED	Class IIa	Active
Crisel	1581-011	EUDAMED	Class IIa	Active
Orthodontic Archwires	6122-2125-I	EUDAMED	Class IIa	Active
Mini Bondable	3111-1211	EUDAMED	Class IIa	Active
Orthodontic Archwires	6112-1400-IT	EUDAMED	Class IIa	Active
Orthodontic Archwires	6121-2125-T	EUDAMED	Class IIa	Active
Aso	1114-045Hd	EUDAMED	Class IIa	Active
Crisel	1594-025	EUDAMED	Class IIa	Active
Tonia	3122-4512	EUDAMED	Class IIa	Active
Mico	2131-4112M	EUDAMED	Class IIa	Active
Gleaming	1414-55-345H	EUDAMED	Class IIa	Active
Tolida	2211-3261	EUDAMED	Class IIa	Active
Gleaming	1432-014	EUDAMED	Class IIa	Active
Easter-M	1862-55-345H	EUDAMED	Class IIa	Active
Orthodontic Archwires	IP6121-1722-O	EUDAMED	Class IIa	Active
Orthodontic Archwires	6161-1400-IIT	EUDAMED	Class IIa	Active
V-Slot	1027-013Hd	EUDAMED	Class IIa	Active
Gleaming	1413-045Hm	EUDAMED	Class IIa	Active
Orthodontic Elastics	PC-47C	EUDAMED	Class IIa	Active
Orthodontic Archwires	IP6112-2000-RL	EUDAMED	Class IIa	Active
Sandon	3331-3030	EUDAMED	Class IIa	Active
Orthodontic Archwires	6131-1600EI	EUDAMED	Class IIa	Active
Kola	3322-1038	EUDAMED	Class IIa	Active
Gleaming	1414-025Hd	EUDAMED	Class IIa	Active
V-Slot	1028-014Hm	EUDAMED	Class IIa	Active
Aso	1131-024Hm	EUDAMED	Class IIa	Active
Sandon	3331-2031	EUDAMED	Class IIa	Active
Rato	1531-035Hm	EUDAMED	Class IIa	Active
Gemy	1722-045Hm	EUDAMED	Class IIa	Active
Kola	3321-4029	EUDAMED	Class IIa	Active
G-Coating	MG20-045Hm	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Instruments, Reusable	EPT-00	EUDAMED	Class I	Active
Tolida	2231-2221	EUDAMED	Class IIa	Active
Orthodontic Archwires	6121-1725-O	EUDAMED	Class IIa	Active
Premolar	3313-3003	EUDAMED	Class IIa	Active
Rato	1511-021	EUDAMED	Class IIa	Active
OneBlock	1342-014Hd	EUDAMED	Class IIa	Active
Rica	1561-025Hd	EUDAMED	Class IIa	Active
Orthodontic Archwires	6161-2000-N	EUDAMED	Class IIa	Active
Orthodontic Archwires	IP6132-1825EI	EUDAMED	Class IIa	Active
Aso	1114-034Hm	EUDAMED	Class IIa	Active
Thino	1214-032	EUDAMED	Class IIa	Active

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Authorised Representatives

Bio Concept, Unipessoal, Lda PT

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.

Astar Orthodontics Inc. US