# Hsiner Co., Ltd. (contract manufacturer, Taichung City, TW): 2 new FDA device listings, incl. attachment, breathing, positive end expiratory pressure

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Hsiner Co., Ltd. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Taichung City, TW |
| New listings | 2 |
| Devices | Attachment, Breathing, Positive End Expiratory Pressure; Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
| Product codes | BYE, CAP |
| Device classes | Class II |
| Medical specialties | Anesthesiology |
| Brand names | The BAG PEEP Valve; The BAG Manometer |
| First new listing | 2026-05-23 |
| Latest new listing | 2026-05-23 |
| FDA registration number | 3003862188 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.

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: 2026-10-28T20:51:27.468Z.
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.