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OrbusNeich Medical (Shenzhen) Co.,Ltd

China·CN-MF-000011345

Last updated June 8, 2026

Information

Country: China
Address: 1, Jinkui Road, People's Republic of China, China
Website: orbusneich.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Anny Wei
EUDAMED SRN: CN-MF-000011345
FDA FEI Number: —
DUNS Number: —

Catalogue (864)

Page 2 of 18

Device	Model / Reference	Registries	Class	Status
Sapphire NC 24	230-264-5J	EUDAMED	Class III	Active
Jade Pta (jade 18 Otw)	594010035	EUDAMED	Class IIa	Active
Jade Pta (jade 18 Otw)	597002035	EUDAMED	Class IIa	Active
Sapphire NC 24	230-154-5J	EUDAMED	Class III	Active
Scoreflex PTA	AM630-204C	EUDAMEDFDA UDI	Class IIa	Active
Scoreflex PTA	BL645-154C	EUDAMEDFDA UDI	Class IIa	Active
Scoreflex PTA	AL620-204N	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 14 Otw)	582002035	EUDAMED	Class IIa	Active
Jade Pta (jade 14 Otw)	584018015	EUDAMED	Class IIa	Active
Jade Pta (jade 35 Otw)	603006025	EUDAMED	Class IIa	Active
Sapphire II PRO	232-103-5UJ	EUDAMED	Class III	Active
Sapphire II (RX)	234-R-1710J2	EUDAMED	Class III	Active
Jade Pta (jade 14 Otw)	582512025	EUDAMED	Class IIa	Active
Scoreflex PTA	AL640-154C	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 18 Otw)	594502025	EUDAMED	Class IIa	Active
Scoreflex PTA	BM630-204C	EUDAMEDFDA UDI	Class IIa	Active
Scoreflex PTA	AS650-204C	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 18 Otw)	591518025	EUDAMED	Class IIa	Active
Jade Pta (jade 18 Otw)	593504015	EUDAMED	Class IIa	Active
Sapphire II NC	117-3015J	EUDAMED	Class III	Active
Scoreflex PTA	AL630-154C	EUDAMEDFDA UDI	Class IIa	Active
Scoreflex PTA	BL640-204C	EUDAMEDFDA UDI	Class IIa	Active
Sapphire NC 24	215-124-5J	EUDAMED	Class III	Active
Sapphire NC 24	220-154-5J	EUDAMED	Class III	Active
Scoreflex PTA	BS640-404C	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 14 Otw)	586006015	EUDAMED	Class IIa	Active
Scoreflex PTA	AL620-404C	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 18 Rx)	557001515	EUDAMED	Class IIa	Active
Jade Pta (jade 18 Rx)	552015015	EUDAMED	Class IIa	Active
Scoreflex PTA	BM640-204C	EUDAMEDFDA UDI	Class IIa	Active
Scoreflex PTA	AM645-404C	EUDAMEDFDA UDI	Class IIa	Active
Sapphire II NC	117-4010J	EUDAMED	Class III	Active
Jade Pta (jade 35 Otw)	605006015	EUDAMED	Class IIa	Active
Sapphire II NC	117-2212J	EUDAMED	Class III	Active
Sapphire NC 24	217-264-5J	EUDAMED	Class III	Active
Jade Pta (jade 14 Otw)	583015035	EUDAMED	Class IIa	Active
Jade Pta (jade 18 Otw)	593015035	EUDAMED	Class IIa	Active
Sapphire NC 24	237-184-5J	EUDAMED	Class III	Active
Sapphire ULTRA Coronary Dilatation Catheter	K233505	FDA 510(k)	Class II	Active
JADE PLUS PTA Balloon Dilatation Catheter	K241025	FDA 510(k)	Class II	Active
Teleport Glide Microcatheter	K253361	FDA 510(k)	Class II	Active
Sapphire NC ULTRA Coronary Dilatation Catheter	K233499	FDA 510(k)	Class II	Active
COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)	K242588	FDA 510(k)	Class II	Active
Teleport XT Microcatheter	K231608	FDA 510(k)	Class II	Active
Jade Pta	L540-35020	EUDAMED	Class IIa	Active
Jade Plus	5835-060-12	EUDAMEDFDA UDI	Class IIa	Active
Jade Plus	5825-240-32	EUDAMEDFDA UDI	Class IIa	Active
Teleport Glide	9235-135-11	EUDAMED	Class IIa	Active
Sapphire II (RX)	234-R-2012J	EUDAMED	Class III	Active
Jade Plus	5830-040-12	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Quality First International OÜ EE

Importers

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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.

OrbusNeich Medical (ShenZhen) Co., Ltd. US