Identity
- Trade Name
- Coflex NL EUDAMEDFDA UDI
- Generic Name
- Pressure bandage, non-latex, single-use FDA UDI
- Device Name
- COFLEX EUDAMEDCohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap, TAN, 4" X 5 Yds FDA UDI
- Model / Reference
- CoFlex NL EUDAMED5400TN-018 EUDAMEDTAN, 4" X 5 Yds FDA UDI
- Description
- Cohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap, TAN, 4" X 5 Yds FDA UDI
Identifiers
- Catalog Number
- 5400TN-018 FDA UDI
- Primary DI / UDI-DI
- 00724004541078 EUDAMED10724004541075 FDA UDI
- Basic UDI-DI
- 0724004CoFlexNLQG EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- M030402020101 ELASTIC SUPPORT BANDAGES, COHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY EUDAMED
- GMDN Term
- Pressure bandage, non-latex, single-use 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
No
EUDAMED
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
Category: Pressure bandage, non-latex, single-use
Coflex NL 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 d2fcc524-c674-4de4-ad5b-6e018dbe6047 35 fields · synced Oct 7, 2026
- EUDAMED 8bb89fa3-c2de-4a75-ad03-b8ebc278b5c1 61 fields · synced Oct 7, 2026