Bioteke Corporation (Wuxi) Co., Ltd (manufacturer, Wuxi City Jiangsu, CN): 10 new FDA device listings, incl. test, opiates, over the counter
Bioteke Corporation (Wuxi) Co., Ltd (Wuxi City Jiangsu): 10 new FDA device listings, incl. test, opiates, over the counter. Its amount of 10 is top-decile (92nd percentile of 2,709 records). Dated 49 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: 10 · 92th percentile of 2,709 DeviceEstablishmentPulse records · 5.0x 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 | Bioteke Corporation (Wuxi) Co., Ltd |
| Owner / operator | BioTeke Corporation (Wuxi) Co., Ltd |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Wuxi City Jiangsu, CN |
| New listings | 10 |
| Devices | Test, Opiates, Over The Counter; Test, Phencyclidine (Pcp), Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Barbiturate, Over The Counter; Test, Amphetamine, Over The Counter; Test, Tricyclic Antidepressants, Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Cannabinoid, Over The Counter; Test, Methadone, Over The Counter; Test, Methamphetamine, Over The Counter |
| Product codes | NGL, NGM, NFV, PTH, NFT, QAW, NFY, NFW, PTG, NGG |
| Device classes | Class II, Unclassified |
| Medical specialties | Clinical Toxicology |
| Brand names | BioTeke® Multi-Drug Urine Test Cup |
| First new listing | 2026-09-17 |
| Latest new listing | 2026-09-17 |
| FDA registration number | 3016837106 |
| Registration expires | 2026-12-31 |
| amount percentile | 92th of 2,709 (median 2, 5.0x 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: 2026-09-17
- 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: Bioteke Corporation (Wuxi) Co., Ltd and 720 CN peers
- CN DeviceEstablishmentPulse records like this one: 720
- Bioteke Corporation (Wuxi) Co., Ltd's amount: 92nd 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 Bioteke Corporation (Wuxi) Co., Ltd in Wuxi City Jiangsu?
Bioteke Corporation (Wuxi) Co., Ltd (Wuxi City Jiangsu, CN), a manufacturer, added 10 FDA device listings on 2026-09-17.
How does Bioteke Corporation (Wuxi) Co., Ltd compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 10 is 5.0x the median of 2 across 2,709 records. It is 49 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.
Bioteke Corporation (Wuxi) Co., Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Bioteke Corporation (Wuxi) Co., Ltd | Wuxi City Jiangsu, CN | 10 | 92nd | 2026-09-17 |
| Boston Scientific Corporation | Coventry, RI | 10 | 92nd | 2026-10-16 |
| Biomerieux, Inc. | Hazelwood, MO | 12 | 94th | 2026-10-22 |
| Intuitive Surgical, Inc. | Sunnyvale, 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.