Identity
- Trade Name
- Therafoam EUDAMEDFDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- Compression Foam EUDAMEDTherafoam Uncoated Wraps 6 Pack FDA UDI
- Model / Reference
- TRRU-6 EUDAMEDFDA UDI
- Description
- Therafoam Uncoated Wraps 6 Pack FDA UDI
Identifiers
- Catalog Number
- TRRU-6 FDA UDI
- Primary DI / UDI-DI
- 00850014883133 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850014883BTD003PT EUDAMED
- 510(k) Number
- K991604 FDA UDI
- FDA Product Code
- MDA FDA UDI
- EMDN Code
- M040299 NON-ADHESIVE ABSORBENT DRESSINGS - OTHER 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
Therafoam 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 | 0850014883BTD003PT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biodermis Llc
- EUDAMED SRN
- US-MF-000010640
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 3be02dac-f020-4274-89a4-d9e0a06d0912 61 fields · synced Jun 8, 2026
- FDA UDI e701172b-abc4-4563-a653-db180645e124 36 fields · synced May 30, 2026