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CoFlex LF2
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9400CP-018Model CoFlex LF2Ref 9303TN-0112Ref 9200CP-036Ref 9100TN-030Ref 9300CP-024Ref 9400TN-018Ref 9606TN-056Ref 9404TN-084Ref 9200TN-036
Identity
- Trade Name
- CoFlex LF2 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 LF2 EUDAMED9400CP-018 EUDAMED9303TN-0112 EUDAMED9200CP-036 EUDAMED9100TN-030 EUDAMED9300CP-024 EUDAMED9400TN-018 EUDAMED9606TN-056 EUDAMED9404TN-084 EUDAMED9200TN-036 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
- 9400TN-018 FDA UDI
- Primary DI / UDI-DI
- 00724004604896 EUDAMED00724004605251 EUDAMEDFDA UDI30724004612878 EUDAMED00724004604872 EUDAMED00724004605213 EUDAMED00724004604889 EUDAMED30724004612892 EUDAMED30724004612885 EUDAMED00724004605237 EUDAMED
- Basic UDI-DI
- 0724004CoFlexLF286 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
CoFlex LF2 by Andover Healthcare Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: CoFlex® LF2
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 | 0724004CoFlexLF286 | 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 (11)
- EUDAMED d8a7f672-fa69-4022-869a-5e405d35fe8c 61 fields · synced Oct 6, 2026
- FDA UDI 214b8126-aa5d-46a1-b587-658a350695e5 35 fields · synced May 29, 2026
- EUDAMED 072742df-4a87-41b3-a60d-467039c5e4e3 61 fields · synced Jul 8, 2026
- EUDAMED 58724389-89db-44be-9585-1b606cb15c75 61 fields · synced Jul 10, 2026
- EUDAMED 037deeb1-0b8d-48f7-be43-dc147890adb1 61 fields · synced Jul 11, 2026
- EUDAMED 4a1636cc-540e-42e3-879d-3c633d7e692d 61 fields · synced Jul 12, 2026
- EUDAMED e7d649cb-abc5-4630-aa08-021a24a1bf5c 61 fields · synced Jul 15, 2026
- EUDAMED 17bddad7-142e-4e3d-999c-f374120b284e 61 fields · synced Jul 20, 2026
- EUDAMED 485a91c9-931c-4328-8cd2-ca210eb2ecdb 61 fields · synced Jul 27, 2026
- EUDAMED 5fd50cfd-a10d-48c2-bd5e-7c72305f29d9 61 fields · synced Aug 1, 2026
- EUDAMED bb1c0b22-b1c0-410d-a9a3-10a49107c9f2 61 fields · synced Oct 6, 2026