FDA device listing
Bedal12006 (ED,VL2*) - tape and bandage, adhesive - Bedal Flex XS, Bedal Flex S, Bedal Flex M,Insulet5490 (SZ) - PodPals…
FDA device listing 1049615976 · STERIS Corporation
Key facts
| Proprietary names | Bedal12006 (ED,VL2*) - tape and bandage, adhesive - Bedal Flex XS, Bedal Flex S, Bedal Flex M,Insulet5490 (SZ) - PodPals Adhesive Overlay |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10042227 |
| Product codes | KGX |
| Device names | KGX - Tape And Bandage, Adhesive |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5240 |
| Review panels | General Hospital |
| Registered establishments | STERIS Sterilization Technologies (Suzhou) Ltd, Synergy Health Ede BV, Synergy Health Sterilisation UK Ltd |
| Establishment registrations | 3002807310, 3008824097, 3009756327, 3010155661, 3020976354 |
| FEI numbers | 3002807038, 3002807310, 3008824097, 3010155661, 3020976354 |
| Establishment operations | Contract Sterilizer |
| 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