Hangzhou Tongzhou Biotechnology Co., Ltd (repackager or relabeler, Hangzhou Zhejiang, CN): 59 new FDA device listings, incl. test, opiates, over the counter
Hangzhou Tongzhou Biotechnology Co., Ltd (Hangzhou Zhejiang): 59 new FDA device listings, incl. test, opiates, over the counter. Its amount of 59 is top-decile (99th percentile of 2,709 records). Dated 45 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: 59 · 99th percentile of 2,709 DeviceEstablishmentPulse records · 29.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Hangzhou Tongzhou Biotechnology Co., Ltd |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Hangzhou Zhejiang, CN |
| New listings | 59 |
| Devices | Test, Opiates, Over The Counter; Enzyme Immunoassay, Opiates; Test, Tricyclic Antidepressants, Over The Counter; Thin Layer Chromatography, Methamphetamine; Test, Barbiturate, Over The Counter; Test, Morphine, Over The Counter; Test, Cannabinoid, Over The Counter; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Cannabinoids; Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Product codes | NGL, DJG, QAW, DJC, PTH, NGI, NFW, DIS, LDJ, LFG, DIO, NFT, JXM, NFV, DNK |
| Device classes | Class II, Unclassified |
| Medical specialties | Clinical Toxicology |
| Brand names | TZcheck Fentanyl Urine Rapid Test Cassette; HINDERING Fentanyl Urine Rapid Test Cassette; HINDERING Multi-Drug Rapid Test Cup; TZcheck Multi-Drug Rapid Test Panel; TZcheck Multi-Drug Rapid Test Panel Rx; TZcheck Multi-Drug Rapid Test Cup Rx; TZcheck Multi-Drug Rapid Test Cup; HINDERING Multi-Drug Rapid Test Panel |
| First new listing | 2026-09-15 |
| Latest new listing | 2026-09-21 |
| FDA registration number | 3021986677 |
| Registration expires | 2027-12-31 |
| amount percentile | 99th of 2,709 (median 2, 29.5x 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: 2026-09-21
- 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: Hangzhou Tongzhou Biotechnology Co., Ltd and 720 CN peers
- CN DeviceEstablishmentPulse records like this one: 720
- Hangzhou Tongzhou Biotechnology Co., Ltd's amount: 99th 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
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Hangzhou Tongzhou Biotechnology Co., Ltd in Hangzhou Zhejiang?
Hangzhou Tongzhou Biotechnology Co., Ltd (Hangzhou Zhejiang, CN), a repackager or relabeler, added 59 FDA device listings between 2026-09-15 and 2026-09-21.
How does Hangzhou Tongzhou Biotechnology Co., Ltd compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 59 is 29.5x the median of 2 across 2,709 records. It is 45 days old, still within a typical 45-day follow-up window.
Hangzhou Tongzhou Biotechnology Co., Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Hangzhou Tongzhou Biotechnology Co., Ltd | Hangzhou Zhejiang, CN | 59 | 99th | 2026-09-21 |
| Oketz Logistics LLC | Coral Gables, FL | 62 | 99th | 2026-10-21 |
| Oketz Logistics LLC | Coral Gables, FL | 56 | 99th | 2026-10-12 |
| Cgbio USA, Inc. | Irvine, CA | 47 | 99th | 2026-10-13 |
Related records
DeviceEstablishmentPulse: Repackager or relabeler 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.