A Cute Baby, Inc. (other, Orem, UT): 1 new FDA device listing, incl. pump, breast, powered
A Cute Baby, Inc. (Orem, Utah): 1 new FDA device listing, incl. pump, breast, powered. Its amount of 1 is above the median of 2 (50th percentile). Dated 167 days ago, it serves as a historical benchmark. Score 50/100. 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: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 34 related UT DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | A Cute Baby, Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Orem, UT, US |
| New listings | 1 |
| Devices | Pump, Breast, Powered |
| Product codes | HGX |
| Device classes | Class II |
| Medical specialties | Obstetrics/Gynecology |
| Brand names | Amaris |
| First new listing | 2026-05-22 |
| Latest new listing | 2026-05-22 |
| FDA registration number | 3009243271 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (35 UT 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: 2026-05-22
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (UT first): Sterigenics U.S., LLC (contract sterilizer, Salt Lake City, · Zigg Design LLC (contract manufacturer, Nibley, UT) · Bard Access Systems, Inc. (other, Salt Lake City, UT) · Isomedix Operations Inc. (contract sterilizer, Sandy, UT) · Merit Medical Systems, Inc. (manufacturer, South Jordan, UT) · Browse all by state and category →
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: A Cute Baby, Inc. and 35 Utah peers
- Utah DeviceEstablishmentPulse records like this one: 35
- A Cute Baby, Inc.'s amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Utah peer: $7,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
50 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for A Cute Baby, Inc. in Orem, Utah?
A Cute Baby, Inc. (Orem, UT), a other, added 1 FDA device listing on 2026-05-22.
How does A Cute Baby, Inc. compare to other Utah DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 167 days old; check the official source for later updates before acting.
A Cute Baby, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| A Cute Baby, Inc. | Orem, UT | 1 | 50th | 2026-05-22 |
| Conmed Corporation | Utica, NY | 3 | 77th | 2026-09-14 |
| Merz North America, Inc. | Sturtevant, WI | 4 | 83rd | 2026-09-23 |
| Rapid Medical Inc. | Southlake, TX | 4 | 83rd | 2026-09-20 |
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DeviceEstablishmentPulse: Other DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in Utah
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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.