Bioxin Medical Co., Ltd (contract manufacturer, Weihai Shandong, CN): 2 new FDA device listings, incl. catheter, intravascular, diagnostic
Bioxin Medical Co., Ltd (Weihai Shandong): 2 new FDA device listings, incl. catheter, intravascular, diagnostic. Its amount of 2 is above the median of 2 (69th percentile). Dated 156 days ago, it serves as a historical benchmark. Score 55/100. 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 | Bioxin Medical Co., Ltd |
| Owner / operator | Bioptimal International PTE Ltd |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Weihai Shandong, CN |
| New listings | 2 |
| Devices | Catheter, Intravascular, Diagnostic; Catheter, Flow Directed |
| Product codes | DQO, DYG |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | Bioptimal Pulmonary Artery Monitoring Catheter |
| First new listing | 2026-06-02 |
| Latest new listing | 2026-06-02 |
| FDA registration number | 3040153768 |
| Registration expires | 2026-12-31 |
| amount percentile | 69th of 2,709 (median 2, 1.0x median) |
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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: 2026-06-02
- 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: Bioxin Medical Co., Ltd and 720 CN peers
- CN DeviceEstablishmentPulse records like this one: 720
- Bioxin Medical Co., Ltd's amount: 69th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $144,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Bioxin Medical Co., Ltd in Weihai Shandong?
Bioxin Medical Co., Ltd (Weihai Shandong, CN), a contract manufacturer, added 2 FDA device listings on 2026-06-02.
How does Bioxin Medical 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 156 days old; check the official source for later updates before acting.
Bioxin Medical Co., Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Bioxin Medical Co., Ltd | Weihai Shandong, CN | 2 | 69th | 2026-06-02 |
| Tecomet Inc. | Wilmington, MA | 3 | 77th | 2026-10-15 |
| Bard Shannon Limited | Humacao, PR | 3 | 77th | 2026-10-14 |
| Orchid Orthopedic Solutions Oregon, Inc. | Oregon City, OR | 3 | 77th | 2026-10-05 |
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DeviceEstablishmentPulse: Contract 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.