OrbusNeich Medical (Shenzhen) Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 5 device types, 18 products catalogued, 9 clearances.
OrbusNeich Medical (Shenzhen) Co., Ltd. is a complaint-file establishment holding a current FDA establishment registration. The registration covers Catheter, Percutaneous, Catheter, Percutaneous, Cutting/Scoring and 3 other device types. 17 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3003775186 |
| FEI number | 3003775186 |
| DUNS | 530923226 |
| Establishment type | Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 业聚医疗器械（深圳）有限公司 |
|---|---|
| Unified social credit code | 91440300715281934U |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | No.1st Jinkui Road, FUTIAN FREE TRADE ZONE, Shenzhen, China; |
| Postal code | 518038 |
| Country | China |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Jade Plus PTA Balloon Dilatation Catheter / Jade Plus 18 OTW | LIT | 832 |
| Jade PTA Balloon Dilatation Catheter | LIT | 667 |
| Sapphire NC 24 Coronary Dilatation Catheter | LOX | 98 |
| Sapphire NC Ultra Coronary Dilatation Catheter | LOX | 60 |
| Scoreflex PTA Scoring Balloon Catheter | LIT | 59 |
| Scoreflex PTA Scoring Balloon Catheter | PNO | 58 |
| Sapphire NC Plus | LOX | 55 |
| Jade PTA | LIT | 46 |
| Sapphire Ultra Coronary Dilatation Catheter | LOX | 45 |
| Sapphire II Pro | LOX | 37 |
| Teleport Glide Microcatheter | DQY | 22 |
| Sapphire II PRO Balloon Dilatation Catheter | LOX | 8 |
| Sapphire II Pro | LIT | 8 |
| Teleport Microcatheter | DQY | 4 |
| Corepass Modular Microcatheter | DQY | 4 |
| Teleport XT Microcatheter | DQY | 3 |
| Jade PTA Balloon Dilatation Catheter | FDA | 1 |
Clearances
9 clearances name OrbusNeich Medical (Shenzhen) Co., Ltd. as applicant. 5 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253361 | 2026-04-10 | DQY | Traditional | This company |
| K242588 | 2025-01-07 | DQY | Traditional | This company |
| K233499 | 2024-08-16 | LOX | Traditional | This company |
| K233505 | 2024-08-15 | LOX | Traditional | This company |
| K241025 | 2024-06-11 | LIT | Traditional | This company |
| K231608 | 2024-01-07 | DQY | Traditional | This company |
| K211807 | 2021-10-14 | LOX | Traditional | This company |
| K202231 | 2020-12-10 | LIT | Traditional | This company |
| K201794 | 2020-07-28 | LIT | Special | This company |
| K200269 | 2020-03-04 | LOX | Special | Orbusneich Medical Trading, Inc. |
| K182713 | 2019-06-11 | PNO | Traditional | Orbusneich Medical Trading, Inc. |
| K182360 | 2018-11-09 | DQY | Traditional | Orbusneich Medical Trading, Inc. |
| K180921 | 2018-06-28 | LOX | Traditional | Orbusneich Medical Trading, Inc. |
| K173894 | 2018-02-09 | LIT | Traditional | Orbusneich Medical Trading, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Main products | Coronary stents, PCI/PTA balloon catheters, PTA balloons, Microcatheters, Structural heart disease products |
| Certifications | CE, FDA, NMPA, PMDA |
| Export markets | Over 70 countries and regions including Belgium, France, Germany, Japan, Singapore, and others |
PMA Approvals
A premarket approval is the Class III route: granted on clinical evidence, not on equivalence to a device already on the market.
| PMA number | Decision | Trade name | Product code |
|---|---|---|---|
| P200041 | 2025-04-29 | Scoreflex NC Scoring PTCA Catheter | NWX |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.