Fenwal International, Inc. (manufacturer, HAINA San Cristobal, DO): 1 new FDA device listing, incl. separator, automated, blood cell, diagnostic
Fenwal International, Inc. (HAINA San Cristobal): 1 new FDA device listing, incl. separator, automated, blood cell, diagnostic. Its amount of 1 is above the median of 1 (50th percentile). Dated 44 days ago, it serves as a historical benchmark. Score 70/100. 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: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 4 related DO DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Fenwal International, Inc. |
| Owner / operator | Fresenius Kabi AG |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | HAINA San Cristobal, DO |
| New listings | 1 |
| Devices | Separator, Automated, Blood Cell, Diagnostic |
| Product codes | GKT |
| Device classes | Class II |
| Medical specialties | Hematology |
| Brand names | Plasmacell-C Disposable Set |
| First new listing | 2026-09-22 |
| Latest new listing | 2026-09-22 |
| FDA registration number | 9612051 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (5 DO 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: 2026-09-22
- 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: Fenwal International, Inc. and 5 DO peers
- DO DeviceEstablishmentPulse records like this one: 5
- Fenwal International, Inc.'s amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every DO peer: $1,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Fenwal International, Inc. in HAINA San Cristobal?
Fenwal International, Inc. (HAINA San Cristobal, DO), a manufacturer, added 1 FDA device listing on 2026-09-22.
How does Fenwal International, Inc. compare to other DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 44 days old, still within a typical 45-day follow-up window. Its Score of 70/100 puts it among the stronger signals in this feed.
Fenwal International, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Fenwal International, Inc. | HAINA San Cristobal, DO | 1 | 50th | 2026-09-22 |
| Beacon Biosignals, Inc. | Boston, MA | 3 | 77th | 2026-10-16 |
| Endovascular Engineering, Inc. | Menlo Park, CA | 3 | 77th | 2026-10-14 |
| INNO Holdings Inc. | Millcreek, UT | 3 | 77th | 2026-10-05 |
Related records
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.