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CoFlex TLC Single Zinc
EUDAMEDFDA UDIClass I (EU MDR)
Ref UB830Z-01Model CoFlex TLC Single ZincRef UB840Z-01
Identity
- Trade Name
- CoFlex TLC Single Zinc EUDAMEDUBZ FDA UDI
- Generic Name
- Compression bandaging kit FDA UDI
- Device Name
- COFLEX 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. CoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market. WHT SINGLE RL 3" X 6 Yds FDA UDIUnna Boot Zinc A single roll of soft foam impregnated with Zinc. White SINGLE Roll 4"X6 FDA UDI
- Model / Reference
- CoFlex TLC Single Zinc EUDAMEDUB830Z-01 EUDAMEDUB840Z-01 EUDAMEDWHT SINGLE RL 3" X 6 Yds FDA UDIWhite SINGLE Roll 4"X6 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. CoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market. WHT SINGLE RL 3" X 6 Yds FDA UDIUnna Boot Zinc A single roll of soft foam impregnated with Zinc. White SINGLE Roll 4"X6 FDA UDI
Identifiers
- Catalog Number
- UB830Z-01 FDA UDIUB840Z-01 FDA UDI
- Primary DI / UDI-DI
- 00724004613669 EUDAMED00724004613676 EUDAMED10724004613666 FDA UDI10724004613673 FDA UDI
- Basic UDI-DI
- 0724004COFLEXTLCSNGLZNMD EUDAMED
- FDA Product Code
- KGX 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
- 880.5240 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA 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 UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CoFlex TLC Single Zinc 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 | 0724004COFLEXTLCSNGLZNMD | 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 (4)
- EUDAMED dc23239f-16fa-4d82-9a89-ce98f9eab4f3 61 fields · synced Oct 6, 2026
- FDA UDI 8a90ea6a-e6ae-46ee-a7e0-220cee1a2b17 35 fields · synced May 30, 2026
- FDA UDI 37a6e15c-2bf2-4df5-8c50-eb6f423645ce 35 fields · synced May 30, 2026
- EUDAMED 29b52bf2-9770-4fa0-8745-8547aaa0caab 61 fields · synced Jul 13, 2026