Identity
- Trade Name
- Huibo Medical FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- medical polymer materials imported from USA polymer gel- biological adhesion gel imported from overseas. hydrogel matrix-fine and smooth. Proper consistency and thickness; do not pollute clothing and easy to cleaning for non-greasy; odourless and colorless, can inject quickly into the skin by rubbing. a thin transparent film which is breathable and waterproof can be formed after applying this product to the scar. Not only ensure breath to the skin, but also promote metabolize and lock water to soft scar and eliminate discomfort. Effect of relieving itching. FDA UDI
- Model / Reference
- 15g FDA UDI
- Description
- medical polymer materials imported from USA polymer gel- biological adhesion gel imported from overseas. hydrogel matrix-fine and smooth. Proper consistency and thickness; do not pollute clothing and easy to cleaning for non-greasy; odourless and colorless, can inject quickly into the skin by rubbing. a thin transparent film which is breathable and waterproof can be formed after applying this product to the scar. Not only ensure breath to the skin, but also promote metabolize and lock water to soft scar and eliminate discomfort. Effect of relieving itching. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936943404022 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scar-management dressing, reusable
Huibo Medical by Henan Huibo Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Henan Huibo Medical Co., Ltd.
Sources (1)
- FDA UDI e70e8d50-becf-4227-8a00-83f45ab30c65 33 fields · synced Jun 8, 2026