Data / Medical devices / China / OrbusNeich Medical (Shenzhen) Co., Ltd.
OrbusNeich Medical (Shenzhen) Co., Ltd.: FDA-registered device maker in SHENZHEN Guangdong, China, 15 510(k) clearances and 1 PMA approval
OrbusNeich Medical (Shenzhen) Co., Ltd. is registered with the FDA (registration 3003775186) in SHENZHEN Guangdong, China. It lists 5 device types. The FDA files 15 510(k) clearances and 1 PMA approval under its listings, the newest dated September 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003775186
- Address
- No.1st Jinkui Road, FUTIAN FREE TRADE ZONE, Shenzhen, China; Floor 1 and Floor 3, Tower D, Tong'an industrial park, No.124, Yonghe Rd., Baoan, Shenzhen, China, SHENZHEN Guangdong, China, 518038
- Owner or operator
- ORBUSNEICH MEDICAL CO. LTD (HONG KONG) (9050384)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 2, 2018
- Registered through
- 2027
- Brand names listed
- COREPASS Modular Microcatheter, JADE PLUS PTA Balloon Dilatation Catheter, JADE PTA Balloon Dilatation Catheter, JADE SCORE PTA Scoring Balloon Dilatation Catheter, Jade PTA, Jade PTA Balloon Dilatation Catheter, Sapphire II Pro Coronary Dilatation Catheter, Sapphire NC 24 Coronary Dilatation Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring | NWX | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Cutting/Scoring | PNO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 16, 2026 | K261778 | JADE SCORE PTA Scoring Balloon Dilatation Catheter | PNO | Substantially Equivalent | OrbusNeich Medical (Shenzhen) Co., Ltd. | accessdata.fda.gov |
| 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 Catheter, Percutaneous
- All makers of Catheter, Percutaneous, Cutting/Scoring
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
Updated September 16, 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.