# Cbr Enterprise Limited (foreign exporter, Hong Kong, HK): 50 new FDA device listings, incl. sleeve, limb, compressible

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Cbr Enterprise Limited |
| Owner / operator | CBR Enterprise Limited |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Hong Kong, HK |
| New listings | 50 |
| Devices | Sleeve, Limb, Compressible; Electrosurgical, Cutting & Coagulation & Accessories; Arthroscope; Filter, Infusion Line; Set, Administration, Intravascular; Tubes, Vials, Systems, Serum Separators, Blood Collection; Cover, Biopsy Forceps; Laparoscope, General & Plastic Surgery; Insufflator, Laparoscopic; Dressing, Wound, Drug |
| Product codes | JOW, GEI, HRX, FPB, FPA, JKA, FFF, GCJ, HIF, FRO, MKJ, NHP, CCL, NHQ, BZK |
| Device classes | Class I, Class II, Class III, Unclassified |
| Medical specialties | Cardiovascular, General, Plastic Surgery, Orthopedic, General Hospital, Clinical Chemistry, Gastroenterology, Urology, Obstetrics/Gynecology, Anesthesiology, Clinical Toxicology, Dental |
| Brand names | SLEEVE, LIMB, COMPRESSIBLE; Set, administration, intravascular; COVER,PROBE,CLEAN,TROPHON; DRESSING, WOUND 4"X5" MEPILEX TRANSFER AG (5/BX; SPIROMETER, MONITORING; CONNECTOR; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR; NEEDLE BC 21X1.25 ECL |
| First new listing | 2026-05-06 |
| Latest new listing | 2026-10-14 |
| FDA registration number | 3013557562 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

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.