FDA device listing
BF-MP190F
FDA device listing 1017728480 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | BF-MP190F |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10094475 |
| Premarket submissions | K172726 |
| Product codes | EOB, EOQ, JWH, MBH, OIY |
| Device names | EOB - Nasopharyngoscope (Flexible Or Rigid), EOQ - Bronchoscope (Flexible Or Rigid), JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, MBH - Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, OIY - Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.4680, 874.4760, 888.3560, 888.3565 |
| Review panels | Ear, Nose, & Throat, Orthopedic |
| Registered establishments | NZ BIOMED LIMITED, STRAITS ORTHOPAEDICS (MFG) SDN BHD |
| Establishment registrations | 3025603301, 3033509898, 3036756245, 3042172882 |
| FEI numbers | 3025603301, 3033509898, 3036756245, 3042172882 |
| Establishment operations | Contract Manufacturer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database