# Emsere, Inc. (repackager or relabeler, Peachtree City, GA): 11 new FDA device listings, incl. dynamometer, nonpowered

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Emsere, Inc. |
| Owner / operator | Emsere, Inc |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Peachtree City, GA, US |
| New listings | 11 |
| Devices | Dynamometer, Nonpowered; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, Test, Breath Nitric Oxide; Filter, Bacterial, Breathing-Circuit; Filter, Conduction, Anesthetic; Camera, Ophthalmic, Slit-Scanning |
| Product codes | HRW, ITX, IYN, IYO, MXA, CAH, BSN, QER |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, Radiology, Clinical Toxicology, Anesthesiology, Ophthalmic |
| Brand names | Jamar® Plus+ Hand Dynamometer; Sonoscape E11 incl. Lineair Transducer 18L-A; Niox Vero Airway Inflammation Monitor - (K133898); ET Green - Expiratory filter & mouthpiece for MIP/MEP measurement; Niox Vero; Niox Vero Airway Inflammation Monitor - (K150233); MILLEX - MP FILTER UNIT - (SLMPO25SS/SLMPL25SS); Niox Vero - System, Test, Breath Nitric Oxide (K170983) |
| First new listing | 2026-06-08 |
| Latest new listing | 2026-09-14 |
| FDA registration number | 3010082909 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
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.