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Ubc
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref UB830C-01Model CoFlex TLC Single Calamine
Identity
- Trade Name
- CoFlex TLC Single Calamine EUDAMEDUBC FDA UDI
- Generic Name
- Compression bandaging kit FDA UDI
- Device Name
- COFLEX TLC EUDAMEDUnna Boot Calamine A single roll of soft foam impregnated with calamine. SINGLE RL 3" X 6 Yds FDA UDI
- Model / Reference
- CoFlex TLC Single Calamine EUDAMEDUB830C-01 EUDAMEDSINGLE RL 3" X 6 FDA UDI
- Description
- Unna Boot Calamine A single roll of soft foam impregnated with calamine. SINGLE RL 3" X 6 Yds FDA UDI
Identifiers
- Catalog Number
- UB830C-01 FDA UDI
- Primary DI / UDI-DI
- 00724004613645 EUDAMED10724004613642 FDA UDI
- Basic UDI-DI
- 0724004COFLEXTLCSNGLCALZV 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 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 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
Ubc 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 3f67a38a-b17f-4ce2-8b37-e46c8aff1003 35 fields · synced Jun 20, 2026
- EUDAMED 6d32b0eb-7cef-4c37-a07e-eeb2d425e6fa 61 fields · synced Jun 20, 2026