Orantech Inc. (foreign exporter, Shenzhen Guangdong, CN): 3 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories
Orantech Inc. (Shenzhen Guangdong): 3 new FDA device listings, incl. electrosurgical, cutting & coagulation & accessories. Its amount of 3 is above the median of 1 (77th percentile). Dated 86 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: 3 · 77th percentile of 2,570 DeviceEstablishmentPulse records · 3.0x 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 | Orantech Inc. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Shenzhen Guangdong, CN |
| New listings | 3 |
| Devices | Electrosurgical, Cutting & Coagulation & Accessories; Staple, Removable (Skin); Oximeter |
| Product codes | GEI, GDT, DQA |
| Device classes | Class I, Class II |
| Medical specialties | General, Plastic Surgery, Cardiovascular |
| Brand names | Electrosurgical Pads; Disposable skin staplers; Fingertip Pulse Oximeter |
| First new listing | 2026-06-18 |
| Latest new listing | 2026-08-10 |
| FDA registration number | 3013783488 |
| Registration expires | 2026-12-31 |
| amount percentile | 77th of 2,570 (median 1, 3.0x 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: 2026-08-10
- 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: Orantech Inc. and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Orantech Inc.'s amount: 77th 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 Orantech Inc. in Shenzhen Guangdong?
Orantech Inc. (Shenzhen Guangdong, CN), a foreign exporter, added 3 FDA device listings between 2026-06-18 and 2026-08-10.
How does Orantech Inc. compare to other DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,570 records; the median is 1. It is 86 days old; check the official source for later updates before acting.
Orantech Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Orantech Inc. | Shenzhen Guangdong, CN | 3 | 77th | 2026-08-10 |
| Optikal (Southgate) Ltd | Borehamwood, GB | 3 | 77th | 2026-10-13 |
| Loudwater Trade Finance Ltd | LONDON England, GB | 3 | 77th | 2026-10-09 |
| Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi | Cankaya Ankara, TR | 9 | 92nd | 2026-10-17 |
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DeviceEstablishmentPulse: Foreign exporter 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.