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Coflex Nl
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5150CP-048Model CoFlex NLRef 5150SC-048Ref 5200LC-072Ref 5200NG-036Ref 5300WH-024Ref 5600KP-012Ref 5600TN-072Ref 5400LB-084Ref 5100RB-030Ref 5300KP-024Ref 5200GR-036Ref 5910CP-075Ref 5150RB-048Ref 5200NP-036Ref 5300BL-024Ref 5400TN-0100Ref 5200SC-036Ref 5300PF-0112Ref 5300TN-024Ref 5300RD-024Ref 5400L-018Ref 5100NP-030Ref 5150TN-048Ref 5100LC-072Ref 5100TN-030Ref 5900CP-0125
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, KIDSPACK, 3" X 5 Yds FDA UDICohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap, TAN, 3",X,5,Yds FDA UDICohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap, BLUE, 3" X 5 Yds FDA UDICoFlex NL,Cohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap,TAN, 1"X5Yds FDA UDI
- Model / Reference
- CoFlex NL EUDAMED5150CP-048 EUDAMED5150SC-048 EUDAMED5200LC-072 EUDAMED5200NG-036 EUDAMED5300WH-024 EUDAMED5600KP-012 EUDAMED5600TN-072 EUDAMED5400LB-084 EUDAMED5100RB-030 EUDAMED5300KP-024 EUDAMED5200GR-036 EUDAMED5910CP-075 EUDAMED5150RB-048 EUDAMED5200NP-036 EUDAMED5300BL-024 EUDAMED5400TN-0100 EUDAMED5200SC-036 EUDAMED5300PF-0112 EUDAMED5300TN-024 EUDAMED5300RD-024 EUDAMED5400L-018 EUDAMED5100NP-030 EUDAMED5150TN-048 EUDAMED5100LC-072 EUDAMED5100TN-030 EUDAMED5900CP-0125 EUDAMEDKIDSPACK 3"X5YD FDA UDITAN, 3" X 5 Yds FDA UDIBLUE 3" X 5 Yds FDA UDITAN, 1"X5Yds FDA UDI
- Description
- Cohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap, KIDSPACK, 3" X 5 Yds FDA UDICohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap, TAN, 3",X,5,Yds FDA UDICohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap, BLUE, 3" X 5 Yds FDA UDICoFlex NL,Cohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap,TAN, 1"X5Yds FDA UDI
Identifiers
- Catalog Number
- 5300KP-024 FDA UDI5300TN-024 FDA UDI5300BL-024 FDA UDI5100TN-030 FDA UDI
- Primary DI / UDI-DI
- 00724004551152 EUDAMED00724004603868 EUDAMED00724004619920 EUDAMED00724004521049 EUDAMED00724004531086 EUDAMED00724004601895 EUDAMED30724004400321 EUDAMED20724004400089 EUDAMED00724004600829 EUDAMED00724004601918 EUDAMED00724004603127 EUDAMED00724004402560 EUDAMED00724004601338 EUDAMED00724004521056 EUDAMED00724004531024 EUDAMED30724004400314 EUDAMED00724004602816 EUDAMED20724004616374 EUDAMED00724004531079 EUDAMED00724004531017 EUDAMED00724004611047 EUDAMED00724004511057 EUDAMED00724004551060 EUDAMED00724004619913 EUDAMED00724004511071 EUDAMED00724004571150 EUDAMED10724004601915 FDA UDI10724004531076 FDA UDI10724004531021 FDA UDI10724004511078 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
Yes
EUDAMEDEUDAMEDFDA 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 Nl 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 | 0724004CoFlexNLQG | 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 (30)
- EUDAMED 3ef1c6a2-edb9-4b85-ae89-0094519b1ccb 61 fields · synced Oct 6, 2026
- FDA UDI 3ed58eb8-b9f8-4d88-b053-af18f0544e8d 35 fields · synced May 27, 2026
- FDA UDI 04f8425e-f289-4f69-b3c1-57a71d75d5ef 35 fields · synced May 30, 2026
- FDA UDI 14236d5d-7dd7-494c-a30b-e88d4d2512c7 35 fields · synced May 30, 2026
- FDA UDI 9645983f-8e0f-4059-9304-5ebef6904b63 35 fields · synced May 30, 2026
- EUDAMED 974da8dd-11e3-4a10-a6c2-4e951f84a3b7 61 fields · synced Jun 20, 2026
- EUDAMED 7fdefc91-6173-4866-90e0-7fee61374539 61 fields · synced Jul 8, 2026
- EUDAMED 7b2ba645-2bc3-4b03-badc-32530bdf5a22 61 fields · synced Jul 8, 2026
- EUDAMED 2b4b9149-f3d3-49d5-8c27-c1533005525d 61 fields · synced Jul 8, 2026
- EUDAMED 0123a9f3-9deb-44ac-a782-188207fd33f5 61 fields · synced Jul 9, 2026
- EUDAMED 28a7f0ee-7db8-45b6-bd63-140ac48037b2 61 fields · synced Jul 10, 2026
- EUDAMED 180b1a04-867b-4a5c-973a-4554e483d07c 61 fields · synced Jul 11, 2026
- EUDAMED a269de56-77e0-4677-bcc6-c638cd3be379 61 fields · synced Jul 12, 2026
- EUDAMED fac0475a-b219-4437-a3c5-81b30c88d1ae 61 fields · synced Jul 13, 2026
- EUDAMED 7bf9ddd2-6ae3-4b6c-b9fa-124b4f3b392b 61 fields · synced Jul 14, 2026
- EUDAMED e02bfee0-d70e-424d-a144-894c3c3469fc 61 fields · synced Jul 16, 2026
- EUDAMED e0ce2316-2a6f-4a0c-80a7-02befbaf3fb0 61 fields · synced Jul 16, 2026
- EUDAMED fe88bd42-8d6c-4ae8-b3ea-b9f141e8a10e 61 fields · synced Jul 18, 2026
- EUDAMED 023dfb12-9460-4fb1-8551-0538adad2737 61 fields · synced Jul 21, 2026
- EUDAMED 9ddcc98a-bbb9-45a9-baa9-46156537be65 61 fields · synced Jul 25, 2026
- EUDAMED 1833c46d-96c8-4689-892f-a3fc3235d6c7 61 fields · synced Jul 26, 2026
- EUDAMED 9016066c-3f03-49be-a37a-7b9406328eb1 61 fields · synced Jul 27, 2026
- EUDAMED 8fa030f0-f658-419d-bf42-459525aa420d 61 fields · synced Jul 28, 2026
- EUDAMED 1af8abe5-0cda-4381-a7ff-555a9399f166 61 fields · synced Jul 28, 2026
- EUDAMED 6c956c4b-68ae-4e7e-8074-70a83a770651 61 fields · synced Aug 1, 2026
- EUDAMED e908c662-ad62-4178-886f-a9f4947e03af 61 fields · synced Aug 4, 2026
- EUDAMED a856ac8b-d8ee-4fe9-a534-561052869bbe 61 fields · synced Aug 4, 2026
- EUDAMED cc1c0081-f42e-480b-b604-9a3bafdfbca0 61 fields · synced Aug 4, 2026
- EUDAMED 44ab4018-1fe2-45b0-b7d2-1dbb32c5ffda 61 fields · synced Sep 17, 2026
- EUDAMED df86bb91-7faf-405a-8248-33b96e318d52 61 fields · synced Sep 18, 2026