Is this your brand? Sign in to claim ownership.

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 3 of 18

Device	Model / Reference	Registries	Class	Status
Scoreflex PTA	AL645-154C	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 18 Rx)	551512015	EUDAMED	Class IIa	Active
Jade Plus	5950-040-12	EUDAMEDFDA UDI	Class IIa	Active
Jade Plus	5845-020-12	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 18 Otw)	593502015	EUDAMED	Class IIa	Active
Jade Pta (jade 18 Otw)	592508015	EUDAMED	Class IIa	Active
Jade Pta (jade 14 Otw)	585012015	EUDAMED	Class IIa	Active
Jade Plus	5955-240-12	EUDAMEDFDA UDI	Class IIa	Active
Scoreflex PTA	BM640-404C	EUDAMEDFDA UDI	Class IIa	Active
Sapphire NC 24	235-184-5J	EUDAMED	Class III	Active
Jade Plus	6070-040-12	EUDAMEDFDA UDI	Class IIa	Active
Jade Plus	5935-080-12	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 18 Rx)	553006015	EUDAMED	Class IIa	Active
Jade Pta (jade 14 Otw)	582508025	EUDAMED	Class IIa	Active
Sapphire II NC	117-2510J	EUDAMED	Class III	Active
Jade Pta (jade 14 Otw)	583008025	EUDAMED	Class IIa	Active
Jade Plus	5855-150-22	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 18 Otw)	595502025	EUDAMED	Class IIa	Active
Jade Plus	5860-040-22	EUDAMEDFDA UDI	Class IIa	Active
Sapphire II NC	117-1718J	EUDAMED	Class III	Active
Jade Pta (jade 18 Otw)	593008025	EUDAMED	Class IIa	Active
Jade Pta (jade 35 Otw)	606004015	EUDAMED	Class IIa	Active
Jade Pta (jade 18 Otw)	593518035	EUDAMED	Class IIa	Active
Sapphire 3	215-203-6J	EUDAMEDFDA UDI	Class III	Active
Jade Pta (jade 18 Otw)	597001535	EUDAMED	Class IIa	Active
Jade Pta (jade 18 Rx)	556012015	EUDAMED	Class IIa	Active
Jade Plus	5925-150-22	EUDAMEDFDA UDI	Class IIa	Active
Jade Plus	5915-150-22	EUDAMEDFDA UDI	Class IIa	Active
Scoreflex PTA	AM660-204C	EUDAMEDFDA UDI	Class IIa	Active
Scoreflex PTA	AL635-204C	EUDAMEDFDA UDI	Class IIa	Active
Jade Plus	5835-040-32	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 18 Otw)	596001515	EUDAMED	Class IIa	Active
Sapphire NC 24	222-264-5J	EUDAMED	Class III	Active
Jade Plus	6040-150-22	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 14 Otw)	584015025	EUDAMED	Class IIa	Active
Sapphire II PRO	230-303-5UJ	EUDAMED	Class III	Active
Sapphire II (RX)	234-R-1010J	EUDAMED	Class III	Active
Scoreflex PTA	AL635-404C	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 14 Otw)	583004015	EUDAMED	Class IIa	Active
Jade Pta (jade 35 Otw)	607010035	EUDAMED	Class IIa	Active
Jade Pta (jade 14 Otw)	583002025	EUDAMED	Class IIa	Active
Scoreflex PTA	BM620-404C	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 18 Otw)	593506035	EUDAMED	Class IIa	Active
Jade Plus	5940-080-12	EUDAMEDFDA UDI	Class IIa	Active
Jade Plus	5845-150-12	EUDAMEDFDA UDI	Class IIa	Active
Jade Plus	5850-040-12	EUDAMEDFDA UDI	Class IIa	Active
Jade Pta (jade 35 Otw)	605015025	EUDAMED	Class IIa	Active
Jade Plus	5945-150-12	EUDAMEDFDA UDI	Class IIa	Active
Jade Plus	5840-150-12	EUDAMEDFDA UDI	Class IIa	Active
Scoreflex PTA	AL625-154N	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Quality First International OÜ EE

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.

OrbusNeich Medical (ShenZhen) Co., Ltd. US