Identity
- Trade Name
- R&L Medical FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Model / Reference
- J-12cm×3cm×2pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 86972949026048 FDA UDI
- FDA Product Code
- PFP FDA UDI
- GMDN Term
- Scar-management dressing, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scar-management dressing, reusable
R&L Medical by Hangzhou R&L Medical Device Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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- THERAFOAM — BIODERMIS LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou R&L Medical Device Co., Ltd
Sources (1)
- FDA UDI 68d5763b-51bc-4f74-8685-3da5e8eddf1e 32 fields · synced May 30, 2026