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CoFlex TLC
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 7802TN-21Model CoFlex TLC Single
Identity
- Trade Name
- CoFlex TLC Single EUDAMEDCoFlex TLC FDA 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. CoFlex® TLC provides a two-step level of comfort. LITE LY2 1" X 3.8 Yds FDA UDI
- Model / Reference
- CoFlex TLC Single EUDAMED7802TN-21 EUDAMEDLITE LY2 1" X 3.8 Yds 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. CoFlex® TLC provides a two-step level of comfort. LITE LY2 1" X 3.8 Yds FDA UDI
Identifiers
- Catalog Number
- 7802TN-21 FDA UDI
- Primary DI / UDI-DI
- 00724004621497 EUDAMED10724004621494 FDA UDI
- Basic UDI-DI
- 0724004CoFlexTLCSingleYN EUDAMED
- FDA Product Code
- MHW 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
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
Category: Compression bandaging kit
CoFlex TLC 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 323f2be3-7784-489b-988c-91da975ed59f 35 fields · synced Jun 18, 2026
- EUDAMED 808b852a-9fdf-400c-8de3-c35e4b3f3078 61 fields · synced Jun 18, 2026