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AndoFlex TLC
EUDAMEDFDA UDIClass I (EU MDR)
Ref ASP-7805TLC-TNModel AndoFlex TLC
Identity
- Trade Name
- AndoFlex TLC EUDAMEDFDA UDI
- Generic Name
- Compression bandaging kit FDA UDI
- Device Name
- COFLEX TLC EUDAMEDTwo-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. AndoFlex® TLC provides a two-step level of comfort W/IND 4" FDA UDI
- Model / Reference
- AndoFlex TLC EUDAMEDASP-7805TLC-TN EUDAMEDW/IND 4" FDA UDI
- Description
- Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. AndoFlex® TLC provides a two-step level of comfort W/IND 4" FDA UDI
Identifiers
- Catalog Number
- ASP-7805TLC-TN FDA UDI
- Primary DI / UDI-DI
- 00724004614925 EUDAMED10724004614922 FDA UDI
- Basic UDI-DI
- 0724004AndoFlexTLCPG EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- M03040299 ELASTIC SUPPORT BANDAGES - OTHER 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
AndoFlex TLC by Andover Healthcare Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0724004AndoFlexTLCPG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Andover Healthcare Inc.
- EUDAMED SRN
- US-MF-000035055
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 99d48768-0102-4a98-be1b-d38d5de5273c 61 fields · synced Jul 9, 2026
- FDA UDI 6009a337-e052-47ef-946d-63315284ea87 35 fields · synced May 30, 2026