OrbusNeich Medical (Shenzhen) Co., Ltd. (manufacturer, SHENZHEN Guangdong, CN): 2 new FDA device listings, incl. catheter, percutaneous, cutting/scoring
OrbusNeich Medical (Shenzhen) Co., Ltd. (SHENZHEN Guangdong): 2 new FDA device listings, incl. catheter, percutaneous, cutting/scoring. Its amount of 2 is above the median of 2 (69th percentile). Dated 18 days ago, it is in the active follow-up window. Score 70/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,709 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | OrbusNeich Medical (Shenzhen) Co., Ltd. |
| Owner / operator | Orbusneich Medical Co. Ltd (Hong Kong) |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | SHENZHEN Guangdong, CN |
| New listings | 2 |
| Devices | Catheter, Percutaneous, Cutting/Scoring; Catheter, Percutaneous |
| Product codes | PNO, DQY |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | JADE SCORE PTA Scoring Balloon Dilatation Catheter; Teleport Glide Microcatheter |
| First new listing | 2026-06-04 |
| Latest new listing | 2026-10-19 |
| FDA registration number | 3003775186 |
| Registration expires | 2027-12-31 |
| amount percentile | 69th of 2,709 (median 2, 1.0x median) |
| Peer records CSV (500 CN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-10-19
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: OrbusNeich Medical (Shenzhen) Co., Ltd. and 720 CN peers
- CN DeviceEstablishmentPulse records like this one: 720
- OrbusNeich Medical (Shenzhen) Co., Ltd.'s amount: 69th percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every CN peer: $144,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for OrbusNeich Medical (Shenzhen) Co., Ltd. in SHENZHEN Guangdong?
OrbusNeich Medical (Shenzhen) Co., Ltd. (SHENZHEN Guangdong, CN), a manufacturer, added 2 FDA device listings between 2026-06-04 and 2026-10-19.
How does OrbusNeich Medical (Shenzhen) Co., Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,709 records; the median is 2. It is 18 days old, still within a typical 45-day follow-up window. Its Score of 70/100 puts it among the stronger signals in this feed.
OrbusNeich Medical (Shenzhen) Co., Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| OrbusNeich Medical (Shenzhen) Co., Ltd. | SHENZHEN Guangdong, CN | 2 | 69th | 2026-10-19 |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 |
| Tornier, Inc. | Bloomington, MN | 3 | 77th | 2026-10-21 |
| Treace Medical Concepts, Inc. | Ponte Vedra, FL | 3 | 77th | 2026-10-20 |
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DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: Foreign establishment
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.