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OrbusNeich Medical, B.V.

Netherlands·NL-MF-000010907

Last updated September 17, 2026

About

Forging new paths in the treatment of vascular diseases with our range of innovative devices including balloons, stents and speciality catheters

From the manufacturer's own website. Source

What OrbusNeich Medical, B.V. makes

OrbusNeich Medical, B.V. manufactures a range of coronary and peripheral vascular devices, including drug-eluting balloons (such as the Sapphire II NC and Sapphire NC 24) and drug-coated balloons (e.g., the Combo Plus). Their portfolio also includes drug-eluting stents (e.g., Sapphire 3) designed for percutaneous coronary intervention and peripheral artery treatments.

The company’s devices are classified under EU regulations as Class III (e.g., drug-eluting stents) and Class IIa (e.g., drug-eluting balloons), with all products listed in the EU’s eudamed registry. The manufacturer is based in the Netherlands.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does OrbusNeich Medical, B.V. manufacture?

OrbusNeich Medical, B.V. specializes in vascular devices used to treat coronary and peripheral artery diseases. Their portfolio includes drug-eluting balloons (like the Sapphire II NC and Sapphire NC 24), drug-coated balloons (such as the Combo Plus), and drug-eluting stents (e.g., Sapphire 3). These devices are designed for procedures like percutaneous coronary intervention and peripheral artery treatments.

Where is OrbusNeich Medical, B.V. based?

OrbusNeich Medical, B.V. is headquartered in the Netherlands. The company’s location in the EU ensures compliance with regional regulatory frameworks for medical device manufacturing and distribution.

Which regulatory registries list OrbusNeich Medical, B.V.’s devices?

OrbusNeich Medical, B.V.’s devices are listed in the eudamed registry, which is the official EU database for medical device information. This registry ensures transparency and traceability of devices under EU regulations.

How are OrbusNeich Medical, B.V.’s devices classified under EU regulations?

OrbusNeich Medical, B.V.’s devices are classified as Class III (e.g., drug-eluting stents) and Class IIa (e.g., drug-eluting balloons) under EU Medical Device Regulations. The classification depends on the device’s risk level and intended use, with Class III requiring the highest scrutiny due to their potential risks.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Netherlands
Address: 5, Drs. W. van Royenstraat, Hoevelaken, Netherlands
Website: orbusneich.com/
LinkedIn: linkedin.com/company/orbusneich-medical
Facebook: —
Email: [email protected]
Phone: +31 33 254 1150
PRRC Contact: Tim Kelder
EUDAMED SRN: NL-MF-000010907
FDA FEI Number: —
DUNS Number: —

Catalogue (201)

Page 3 of 5

Device	Model / Reference	Registries	Class	Status
Sapphire II PRO	210-053-5U	EUDAMED	Class III	Active
Sapphire NC 24	228-124-5	EUDAMED	Class III	Active
Scoreflex PTA	645E-20X-31	EUDAMED	Class IIa	Active
Jade PTA	540-180-41	EUDAMED	Class IIa	Active
Scoreflex PTA	630E-40B-31	EUDAMED	Class IIa	Active
Scoreflex PTA	640F-40N-31	EUDAMED	Class IIa	Active
Sapphire NC	235-153-2	EUDAMED	Class III	Active
Sapphire NC 24	230-154-5	EUDAMED	Class III	Active
Sapphire NC 24	235-104-5	EUDAMED	Class III	Active
Sapphire 3	220-103-6	EUDAMED	Class III	Active
Sapphire NC 24	237-154-5	EUDAMED	Class III	Active
Sapphire NC	220-103-2	EUDAMED	Class III	Active
Scoreflex	640-203-1	EUDAMED	Class III	Active
Scoreflex PTA	635F-20X-31	EUDAMED	Class IIa	Active
Sapphire NC 24	235-184-5	EUDAMED	Class III	Active
Jade PTA	535-020-41	EUDAMED	Class IIa	Active
Sapphire NC	240-153-2	EUDAMED	Class III	Active
Scoreflex PTA	645F-40X-31	EUDAMED	Class IIa	Active
Jade PTA	550-040-41	EUDAMED	Class IIa	Active
Jade PTA	555-020-41	EUDAMED	Class IIa	Active
Scoreflex	620-103-1	EUDAMED	Class III	Active
Sapphire NC 24	250-264-5	EUDAMED	Class III	Active
Sapphire 3	208-053-6	EUDAMED	Class III	Active
Scoreflex PTA	640F-15X-31	EUDAMED	Class IIa	Active
Sapphire NC	230-103-2	EUDAMED	Class III	Active
Scoreflex PTA	640E-40B-31	EUDAMED	Class IIa	Active
Sapphire NC 24	217-104-5	EUDAMED	Class III	Active
Scoreflex PTA	640F-40X-31	EUDAMED	Class IIa	Active
Combo Plus	240-332-11	EUDAMED	Class III	Active
Sapphire 3	215-153-6	EUDAMED	Class III	Active
Sapphire II PRO	235-103-5U	EUDAMED	Class III	Active
Sapphire 3	240-153-6	EUDAMED	Class III	Active
Sapphire NC 24	232-154-5	EUDAMED	Class III	Active
Sapphire NC 24	240-264-5	EUDAMED	Class III	Active
Scoreflex PTA	645F-20B-31	EUDAMED	Class IIa	Active
Scoreflex PTA	625E-40X-31	EUDAMED	Class IIa	Active
Sapphire II PRO	230-103-5U	EUDAMED	Class III	Active
Sapphire II PRO	225-103-5U	EUDAMED	Class III	Active
Sapphire NC 24	237-264-5	EUDAMED	Class III	Active
Sapphire NC 24	227-154-5	EUDAMED	Class III	Active
Scoreflex PTA	620E-15X-31	EUDAMED	Class IIa	Active
Sapphire NC 24	235-224-5	EUDAMED	Class III	Active
Sapphire NC24	215-154-5	EUDAMED	Class III	Active
Sapphire NC 24	227-084-5	EUDAMED	Class III	Active
Scoreflex PTA	650F-40A-31	EUDAMED	Class IIa	Active
Scoreflex PTA	645E-40X-31	EUDAMED	Class IIa	Active
Combo Plus	240-152-11	EUDAMED	Class III	Active
Scoreflex PTA	645F-40B-31	EUDAMED	Class IIa	Active
Sapphire NC	222-103-2	EUDAMED	Class III	Active
Scoreflex	630-103-1	EUDAMED	Class III	Active

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