Shanghai Hua En Industrial Co Ltd (repackager or relabeler, Shanghai, CN): 7 new FDA device listings, incl. syringe, piston
Shanghai Hua En Industrial Co Ltd (Shanghai): 7 new FDA device listings, incl. syringe, piston. Its amount of 7 is top-decile (90th percentile of 2,570 records). Dated 69 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-10-28, 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: 7 · 90th percentile of 2,570 DeviceEstablishmentPulse records · 7.0x the median
Free preview: all 13 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Shanghai Hua En Industrial Co Ltd |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Shanghai, CN |
| New listings | 7 |
| Devices | Syringe, Piston; Needle, Hypodermic, Single Lumen; Syringe, Antistick |
| Product codes | FMF, FMI, MEG |
| Device classes | Class II |
| Medical specialties | General Hospital |
| First new listing | 2026-08-28 |
| Latest new listing | 2026-08-28 |
| FDA registration number | 3010147274 |
| Registration expires | 2026-12-31 |
| amount percentile | 90th of 2,570 (median 1, 7.0x 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: 2026-08-28
- Data refreshed: 2026-10-28
- 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, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Shanghai Hua En Industrial Co Ltd and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Shanghai Hua En Industrial Co Ltd's amount: 90th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $137,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Shanghai Hua En Industrial Co Ltd in Shanghai?
Shanghai Hua En Industrial Co Ltd (Shanghai, CN), a repackager or relabeler, added 7 FDA device listings on 2026-08-28.
How does Shanghai Hua En Industrial Co Ltd compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 7 is 7.0x the median of 1 across 2,570 records. It is 69 days old; check the official source for later updates before acting.
Shanghai Hua En Industrial Co Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Shanghai Hua En Industrial Co Ltd | Shanghai, CN | 7 | 90th | 2026-08-28 |
| VIVE Health LLC | Naples, FL | 10 | 93rd | 2026-10-14 |
| Tpc Advanced Technology, Inc. | City Industry, CA | 4 | 83rd | 2026-09-28 |
| Nam Ha Viet Nam Trading Company Limited | Hanoi Ha Noi, VN | 3 | 77th | 2026-09-24 |
Related records
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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.