Koga Isotope Ltd. (contract sterilizer, Koka-shi Shiga, JP): 2 new FDA device listings, incl. protective coating, mucoadhesive application, for the rectal mucosa
Koga Isotope Ltd. (Koka-shi Shiga): 2 new FDA device listings, incl. protective coating, mucoadhesive application, for the rectal mucosa. Its amount of 2 is above the median of 1 (69th percentile). Dated 80 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: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 13 published fields of this record are shown below. Locked: 60 related JP DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Koga Isotope Ltd. |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Koka-shi Shiga, JP |
| New listings | 2 |
| Devices | Protective Coating, Mucoadhesive Application, For The Rectal Mucosa; Hemostatic Device For Endoscopic Gastrointestinal Use |
| Product codes | PHN, QAU |
| Device classes | Class II, Unclassified |
| Medical specialties | General, Plastic Surgery |
| First new listing | 2026-08-17 |
| Latest new listing | 2026-08-17 |
| FDA registration number | 3002807408 |
| Registration expires | 2026-12-31 |
| amount percentile | 69th of 2,570 (median 1, 2.0x median) |
| Peer records CSV (61 JP 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: 2026-08-17
- 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: Koga Isotope Ltd. and 61 JP peers
- JP DeviceEstablishmentPulse records like this one: 61
- Koga Isotope Ltd.'s amount: 69th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every JP peer: $12,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
What is the DeviceEstablishmentPulse record for Koga Isotope Ltd. in Koka-shi Shiga?
Koga Isotope Ltd. (Koka-shi Shiga, JP), a contract sterilizer, added 2 FDA device listings on 2026-08-17.
How does Koga Isotope Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 80 days old; check the official source for later updates before acting.
Koga Isotope Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Koga Isotope Ltd. | Koka-shi Shiga, JP | 2 | 69th | 2026-08-17 |
| Isomedix Operations Inc. | Chester, NY | 3 | 77th | 2026-09-28 |
| Isomedix Operations, Inc | Ontario, CA | 7 | 90th | 2026-10-15 |
| Isomedix Operations, Inc. | Libertyville, IL | 7 | 90th | 2026-10-15 |
Related records
DeviceEstablishmentPulse: Contract sterilizer 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.