Identity
- Trade Name
- Areza Medical FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
- Device Name
- AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoallergenic nature and ease of removal make it an ideal tape for patients with fragile skin or sensitivity to acrylic adhesives. Areza Silicone Tape consists of a polyurethane film carrier (backing) and a potent adhesive silicone gel. The combination of strong adhesion and skin-friendliness makes this tape ideal for applications requiring a secure hold without causing skin irritation. This tape finds versatile applications in various healthcare settings and conditions, providing extended wear time. It is commonly used in wound care, post-surgery recovery, and medical device fixation, among other healthcare applications. FDA UDI
- Model / Reference
- ST15501 FDA UDI
- Description
- AREZA Silicone Tape is a genuinely hypoallergenic tape that offers strong adhesion. Its hypoallergenic nature and ease of removal make it an ideal tape for patients with fragile skin or sensitivity to acrylic adhesives. Areza Silicone Tape consists of a polyurethane film carrier (backing) and a potent adhesive silicone gel. The combination of strong adhesion and skin-friendliness makes this tape ideal for applications requiring a secure hold without causing skin irritation. This tape finds versatile applications in various healthcare settings and conditions, providing extended wear time. It is commonly used in wound care, post-surgery recovery, and medical device fixation, among other healthcare applications. FDA UDI
Identifiers
- Catalog Number
- ST15501 FDA UDI
- Primary DI / UDI-DI
- 00850021481636 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 5.46 Yard FDA UDIWidth — 1 Inch FDA UDI
Category: Dressing-fixation skin adhesive tape, non-silicone
Areza Medical by Advanced Medical Associates, Llc — 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
- Advanced Medical Associates, Llc
Sources (1)
- FDA UDI 798f8dd4-d514-431c-a0f1-4d6e198606eb 37 fields · synced Jun 8, 2026