Identity
- Trade Name
- Huibo Medical FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- 1.Comfortable and adhesive: Soft silicone with excellent performance; comfortable; stripping without pain; no skin irritation. 2.Slim and light: 0.5mm thickness. 3.Invisible and sun-resistant. Close to skin-color; good concealment; strong exclusive.; external use without affecting beauty . 4.Flexible and elastic. 5.Easy to cut: Before use, it can be cut economically according to the size of the scar. 6.Able to reuse. There is no skin allergy for long time use everyday. Normally, it can be used one week or so. FDA UDI
- Model / Reference
- 6cm*8cm FDA UDI
- Description
- 1.Comfortable and adhesive: Soft silicone with excellent performance; comfortable; stripping without pain; no skin irritation. 2.Slim and light: 0.5mm thickness. 3.Invisible and sun-resistant. Close to skin-color; good concealment; strong exclusive.; external use without affecting beauty . 4.Flexible and elastic. 5.Easy to cut: Before use, it can be cut economically according to the size of the scar. 6.Able to reuse. There is no skin allergy for long time use everyday. Normally, it can be used one week or so. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936943403100 FDA UDI
- FDA Product Code
- MDA 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 f484633a-f078-45a8-8e67-a73f02d2954d 33 fields · synced Jun 6, 2026