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Beijing Fule Science & Technology Development Co., Ltd.

China·CN-MF-000006511

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Reamer	1010016	EUDAMED	Class I	Active
Open Drill (Ⅳ)	107-400	EUDAMED	Class I	Active
Open Drill (Ⅲ)	313-130	EUDAMED	Class I	Active
Reamer	101-209	EUDAMED	Class I	Active
Tap (Ⅰ)	113-530	EUDAMED	Class I	Active
Open Drill (Ⅰ)	1060005	EUDAMED	Class I	Active
Tap (Ⅱ)	110-449	EUDAMED	Class I	Active
Open Drill (Ⅶ)	201101	EUDAMED	Class I	Active
Open Drill (Ⅵ)	313-120	EUDAMED	Class I	Active
Reamer	1010015	EUDAMED	Class I	Active
Open Drill (Ⅰ)	107-360	EUDAMED	Class I	Active
Open Drill (Ⅱ)	113-013	EUDAMED	Class I	Active
Open Drill (Ⅰ)	107-149	EUDAMED	Class I	Active
Bone Traction Pin (Ⅱ)	9200118	EUDAMED	Class I	Active
COX Monoaxial Pedicle Screw	19900156	EUDAMED	Class IIb	Active
Brokeback Device (Ⅴ)	1905235	EUDAMED	Class I	Active
Fule Spinal Fixation System	K252730	FDA 510(k)	Class II	Active
Orthopedic Holder (Ⅸ)	9200122	EUDAMED	Class I	Active
Orthopedic Holder (Ⅵ)	1906123	EUDAMED	Class I	Active
Cervical Retractor	9200116	EUDAMED	Class I	Active
Wrench (ⅩⅩⅧ)	1905180	EUDAMED	Class I	Active
Cervical Retractor	9200117B	EUDAMED	Class I	Active
Bone Traction Pin (Ⅱ)	9200119	EUDAMED	Class I	Active
Rod Cutter (Ⅰ)	1904320	EUDAMED	Class I	Active
COX Monoaxial Pedicle Screw	19900157	EUDAMED	Class IIb	Active
Orthopedic Holder (Ⅷ)	110-116	EUDAMED	Class I	Active
Orthopedic Distractor	1905181	EUDAMED	Class I	Active
Straight Ti Rod	19901644	EUDAMED	Class IIb	Active
Orthopedic Holder (Ⅱ)	1905182	EUDAMED	Class I	Active
Orthopedic Holder (Ⅶ)	1905264	EUDAMED	Class I	Active

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Not available yet.