Vivachek Biotech (Hangzhou) Co., Ltd (manufacturer, Hangzhou, Zhuji Zhejiang, CN): 12 new FDA device listings, incl. fluorometer, for clinical use
Vivachek Biotech (Hangzhou) Co., Ltd (Hangzhou, Zhuji Zhejiang): 12 new FDA device listings, incl. fluorometer, for clinical use. Its amount of 12 is top-decile (94th percentile of 2,709 records). Dated 72 days ago, it serves as a historical benchmark. Score 75/100. 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: 12 · 94th percentile of 2,709 DeviceEstablishmentPulse records · 6.0x 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 | Vivachek Biotech (Hangzhou) Co., Ltd |
| Owner / operator | VivaChek Biotech (Hangzhou) Co., Ltd |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Hangzhou, Zhuji Zhejiang, CN |
| New listings | 12 |
| Devices | Fluorometer, For Clinical Use; Test, Amphetamine, Over The Counter; Enzyme Immunoassay, Phencyclidine; Test, Propoxyphene, Over The Counter; Test, Barbiturate, Over The Counter; Test, Cannabinoid, Over The Counter; Test, Opiates, Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Methamphetamine, Over The Counter; Test, Methadone, Over The Counter |
| Product codes | KHO, NFT, LCM, QBF, PTH, NFW, NGL, NFV, NGG, PTG, QAW, NFY |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | Clinical Chemistry, Clinical Toxicology |
| Brand names | VivaDiag POCT Analyzer (Models: VIM1000; VIM2000; VIM3000) |
| First new listing | 2026-06-02 |
| Latest new listing | 2026-08-25 |
| FDA registration number | 3013223546 |
| Registration expires | 2026-12-31 |
| amount percentile | 94th of 2,709 (median 2, 6.0x 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: 2026-08-25
- 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: Vivachek Biotech (Hangzhou) Co., Ltd and 720 CN peers
- CN DeviceEstablishmentPulse records like this one: 720
- Vivachek Biotech (Hangzhou) Co., Ltd's amount: 94th 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)
75 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Vivachek Biotech (Hangzhou) Co., Ltd in Hangzhou, Zhuji Zhejiang?
Vivachek Biotech (Hangzhou) Co., Ltd (Hangzhou, Zhuji Zhejiang, CN), a manufacturer, added 12 FDA device listings between 2026-06-02 and 2026-08-25.
How does Vivachek Biotech (Hangzhou) Co., Ltd compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 12 is 6.0x the median of 2 across 2,709 records. It is 72 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Vivachek Biotech (Hangzhou) Co., Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Vivachek Biotech (Hangzhou) Co., Ltd | Hangzhou, Zhuji Zhejiang, CN | 12 | 94th | 2026-08-25 |
| Biomerieux, Inc. | Hazelwood, MO | 12 | 94th | 2026-10-22 |
| Intuitive Surgical, Inc. | Sunnyvale, CA | 13 | 95th | 2026-10-22 |
| Intuitive Surgical, Inc. | Santa Clara, CA | 13 | 95th | 2026-10-22 |
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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.