Data / Medical devices / Hong Kong / Orbusneich Medical Co. Ltd (hong Kong)
Orbusneich Medical Co. Ltd (hong Kong): FDA-registered device maker in Fo Tan, N.T., Hong Kong, 14 510(k) clearances and 1 PMA approval
Orbusneich Medical Co. Ltd (hong Kong) is registered with the FDA (registration 3015002281) in Fo Tan, N.T., Hong Kong. It lists 5 device types. The FDA files 14 510(k) clearances and 1 PMA approval under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015002281
- Address
- Units 303 &305, 3/F, Building 20E, Hong Kong Science Park, Shatin, N.t., Hong Kong No. 27-31 Au Pui Wan Streeet, Fo Tan, N.T., Hong Kong, NA
- Owner or operator
- OrbusNeich Medical Co. Ltd (Hong Kong) (10059958)
- Roles
- Complaint file establishment, Exporter to the US
- First device listed
- March 14, 2019
- Registered through
- 2026
- Brand names listed
- COREPASS Modular Microcatheter, JADE PLUS PTA Balloon Dilatation Catheter, Jade PTA Balloon Dilatation Catheter, Sapphire II PRO Balloon Dilatation Catheter, Sapphire II Pro Coronary Dilatation Catheter, Sapphire NC 24 Coronary Dilatation Catheter, Sapphire NC ULTRA Coronary Dilatation Catheter, Sapphire ULTRA Coronary Dilatation Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring | NWX | 3 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Catheter, Percutaneous, Cutting/Scoring | PNO | 2 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2026 | K253361 | Teleport Glide Microcatheter | DQY | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| January 7, 2025 | K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | DQY | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| August 16, 2024 | K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | LOX | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| August 15, 2024 | K233505 | Sapphire ULTRA Coronary Dilatation Catheter | LOX | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| June 11, 2024 | K241025 | JADE PLUS PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| January 7, 2024 | K231608 | Teleport XT Microcatheter | DQY | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| October 14, 2021 | K211807 | Sapphire NC 24 | LOX | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| December 10, 2020 | K202231 | JADE | LIT | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| July 28, 2020 | K201794 | Jade | LIT | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| March 4, 2020 | K200269 | Sapphire II PRO | LOX | Substantially Equivalent | Orbusneich Medical Trading, Inc. | accessdata.fda.gov |
| June 11, 2019 | K182713 | Scoreflex PTA Scoring Balloon Catheter | PNO | Substantially Equivalent | Orbusneich Medical Trading, Inc. | accessdata.fda.gov |
| November 9, 2018 | K182360 | Teleport Microcatheter | DQY | Substantially Equivalent | Orbusneich Medical Trading, Inc. | accessdata.fda.gov |
| June 28, 2018 | K180921 | Sapphire II PRO Balloon Dilatation Catheter | LOX | Substantially Equivalent | Orbusneich Medical Trading, Inc. | accessdata.fda.gov |
| February 9, 2018 | K173894 | Jade PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Orbusneich Medical Trading, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 21, 2021 | P200041 | Scoreflex NC Scoring PTCA Catheter | NWX | 9 | July 31, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Catheter, Percutaneous, Cutting/Scoring
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheter, Percutaneous
- All makers of Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.