Identity
- Trade Name
- Epiderm Clear EUDAMEDEPI-DERM FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- Silicone Gel Sheeting EUDAMEDTNT Areola Circle, 3" x 0.75", (7.60 OD x 1.90 ID x 0.09cm), 5 Pair FDA UDI
- Model / Reference
- EACTNT-51 EUDAMEDFDA UDI
- Description
- TNT Areola Circle, 3" x 0.75", (7.60 OD x 1.90 ID x 0.09cm), 5 Pair FDA UDI
Identifiers
- Catalog Number
- EACTNT-51 FDA UDI
- Primary DI / UDI-DI
- 00852260000685 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850014883BTD001PP EUDAMED
- 510(k) Number
- K003948 FDA UDI
- FDA Product Code
- MDA FDA UDI
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Scar-management dressing, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4025 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Epiderm Clear by Biodermis Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850014883BTD001PP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biodermis Llc
- EUDAMED SRN
- US-MF-000010640
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 47d12f51-83e3-4bae-9c4b-8a8464da9e93 61 fields · synced Jul 11, 2026
- FDA UDI f4e271ee-b74f-42a3-ba63-bed71a53d57c 36 fields · synced May 26, 2026