Identity
- Trade Name
- Huibo Medical FDA UDI
- Generic Name
- Skin-closing tension device FDA UDI
- Device Name
- Medical skin stretching and secure wound-closure system comprises PP buckle, medical adhesive tape and release paper. FDA UDI
- Model / Reference
- 25*10mm FDA UDI
- Description
- Medical skin stretching and secure wound-closure system comprises PP buckle, medical adhesive tape and release paper. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936943411457 FDA UDI
- FDA Product Code
- FZW FDA UDI
- GMDN Term
- Skin-closing tension device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Skin-closing tension device
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 17b7d05d-d747-4af1-a9a4-242f766b3db4 33 fields · synced Jun 8, 2026