FDA device listing
MEPIFORM 10 X 18 CM PACK 5,MEPIFORM STERIL 4X30CM PACK 5,MEPIFORM STERIL 5X7.5CM PACK 5
FDA device listing 1649108360 · MEDI.PLAN GmbH & Co. KG
Key facts
| Proprietary names | MEPIFORM 10 X 18 CM PACK 5,MEPIFORM STERIL 4X30CM PACK 5,MEPIFORM STERIL 5X7.5CM PACK 5 |
|---|---|
| Owner/operator | MEDI.PLAN GmbH & Co. KG |
| Owner/operator number | 10091549 |
| Product codes | MDA |
| Device names | MDA - Elastomer, Silicone, For Scar Management |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4025 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MEDI.PLAN GMBH & CO. KG |
| Establishment registrations | 3033536319 |
| FEI numbers | 3033536319 |
| Establishment operations | Foreign Exporter |
| 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