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AndoFlex UBZ
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref ASP-8830UBZ-TNModel AndoFlex TLC Zinc Lite
Identity
- Trade Name
- AndoFlex TLC Zinc Lite EUDAMEDAndoFlex UBZ FDA UDI
- Generic Name
- Compression bandaging kit FDA UDI
- Device Name
- AndoFlex TLC EUDAMEDTwo-Layer Kit Layer 1 is a soft foam roll impregnated with zinc that soothes and calms skin. Layer 2 is a non-latex short stretch compression bandage that sticks to itself and features EasyTear technology, eliminating the need for scissors. AndoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market. 4"W/IN TN 3 FDA UDI
- Model / Reference
- AndoFlex TLC Zinc Lite EUDAMEDASP-8830UBZ-TN EUDAMED4"W/IN TN 3 FDA UDI
- Description
- Two-Layer Kit Layer 1 is a soft foam roll impregnated with zinc that soothes and calms skin. Layer 2 is a non-latex short stretch compression bandage that sticks to itself and features EasyTear technology, eliminating the need for scissors. AndoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market. 4"W/IN TN 3 FDA UDI
Identifiers
- Catalog Number
- ASP-8830UBZ-TN FDA UDI
- Primary DI / UDI-DI
- 00724004615953 EUDAMED10724004620886 FDA UDI
- Basic UDI-DI
- 0724004AndFlxTLCZNLiteK2 EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- M030402020101 ELASTIC SUPPORT BANDAGES, COHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY EUDAMED
- GMDN Term
- Compression bandaging kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5075 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Compression bandaging kit
AndoFlex UBZ by Andover Healthcare Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Andover Healthcare Inc.
Sources (2)
- FDA UDI 6552e3c0-40f0-4353-b2ae-860161fd473d 35 fields · synced Jun 14, 2026
- EUDAMED 3822b924-4cdb-47a6-b4d0-11389ddddbcc 61 fields · synced Jun 11, 2026