FDA device listing
Active Micro Plus, Kid 10-14,Active Micro Plus, Kid 6-10,Active Micro Plus, Kids 4-6,Active Micro Plus, L,Active Micro…
FDA device listing 1177655253 · V. GULDMANN A/S
Key facts
| Proprietary names | Active Micro Plus, Kid 10-14,Active Micro Plus, Kid 6-10,Active Micro Plus, Kids 4-6,Active Micro Plus, L,Active Micro Plus, M,Active Micro Plus, S,Active Micro Plus, XL,Active Micro Plus, XS,Active Micro Plus, XXL,Active Micro, Poly, L,Active Micro, Poly, M,Active Micro, Poly, S,Active Micro, Poly, XXL,Active Trainer, Kid 10-14,Active Trainer, Kid 6-10,Active Trainer, L,Active Trainer, M,Active… |
|---|---|
| Owner/operator | V. GULDMANN A/S |
| Owner/operator number | 9027662 |
| Product codes | ILE |
| Device names | ILE - Sling, Arm, Overhead Supported |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | GULDMANN-UKRAINE LTD, V. GULDMANN A/S |
| Establishment registrations | 9710050, 3020157853 |
| FEI numbers | 3002835648, 3020157853 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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