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CoFlex TLC Single Calamine

EUDAMEDFDA UDI

Class I (EU MDR)

Ref UB840C-01Model CoFlex TLC Single CalamineRef 7800TN-16Model CoFlex TLC SingleRef 3100RB-030Model CoFlexRef 7800TN-26Ref 3200CP-036Ref 3100WH-030Ref 3300TN-024Ref 3100TN-030Ref 7800TN-13Ref 7800TN-22Ref 7800TN-12Ref 3150BL-048Ref 3400CP-018Ref 7800TLC-02Model CoFlex TLCRef 3100CP-030Ref 7800TN-24Ref 3100RD-030Ref 3150RB-048

by Andover Healthcare Inc.

Identity

Trade Name
CoFlex TLC Single Calamine EUDAMED
Coflex EUDAMEDFDA UDI
CoFlex TLC EUDAMEDFDA UDI
CoFlex TLC Single EUDAMED
UBC FDA UDI
Generic Name
Compression bandaging kit FDA UDI
Pressure bandage, Hevea-latex, single-use FDA UDI
Device Name
COFLEX TLC EUDAMED
COFLEX EUDAMED
Unna Boot Calamine A single roll of soft foam impregnated with calamine. PK SINGLE Roll 4" X 6 Yds FDA UDI
CoFlex Self Adhering Bandage, CPK, 2" x 5 Yds FDA UDI
CoFlex Self Adherent Compression Bandage, Tan 3"X5 Yds FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. STD LYR2 4" X 5 Yds FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. LY1 FOAM 3" X 3 Yds FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. STD LYR2 2" X 3 Yds FDA UDI
CoFlex Self Adhering Compression Bandage, CPK, 4"X5 Yds FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. LY1 FOAM 6" X 3.8 Yds FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. LY1 FOAM 2" X 1.3 Yds FDA UDI
CoFlex self adhering compression bandage, CPK, 1" x 5 yds. FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. STD LYR2 6" X 5 Yds FDA UDI
Model / Reference
CoFlex TLC Single Calamine EUDAMED
UB840C-01 EUDAMED
CoFlex TLC Single EUDAMED
7800TN-16 EUDAMED
CoFlex EUDAMED
3100RB-030 EUDAMED
7800TN-26 EUDAMED
3200CP-036 EUDAMED
3100WH-030 EUDAMED
3300TN-024 EUDAMED
3100TN-030 EUDAMED
7800TN-13 EUDAMED
7800TN-22 EUDAMED
7800TN-12 EUDAMED
3150BL-048 EUDAMED
3400CP-018 EUDAMED
CoFlex TLC EUDAMED
7800TLC-02 EUDAMED
3100CP-030 EUDAMED
7800TN-24 EUDAMED
3100RD-030 EUDAMED
3150RB-048 EUDAMED
PK SINGLE Roll 4" X 6 Yds FDA UDI
CPK, 2" x 5 Yds FDA UDI
Tan 3"X5 Yds FDA UDI
STD LYR2 4" X 5 Yds FDA UDI
LY1 FOAM 3" X 3 Yds FDA UDI
STD LYR2 2" X 3 Yds FDA UDI
CPK, 4"X5 Yds FDA UDI
LY1 FOAM 6" X 3.8 Yds FDA UDI
LY1 FOAM 2" X 1.3 Yds FDA UDI
CPK, 1" x 5 yds. FDA UDI
STD LYR2 6" X 5 Yds FDA UDI
Description
Unna Boot Calamine A single roll of soft foam impregnated with calamine. PK SINGLE Roll 4" X 6 Yds FDA UDI
CoFlex Self Adhering Bandage, CPK, 2" x 5 Yds FDA UDI
CoFlex Self Adherent Compression Bandage, Tan 3"X5 Yds FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. STD LYR2 4" X 5 Yds FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. LY1 FOAM 3" X 3 Yds FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. STD LYR2 2" X 3 Yds FDA UDI
CoFlex Self Adhering Compression Bandage, CPK, 4"X5 Yds FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. LY1 FOAM 6" X 3.8 Yds FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. LY1 FOAM 2" X 1.3 Yds FDA UDI
CoFlex self adhering compression bandage, CPK, 1" x 5 yds. FDA UDI
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. STD LYR2 6" X 5 Yds FDA UDI

Identifiers

Catalog Number
UB840C-01 FDA UDI
3200CP-036 FDA UDI
3300TN-024 FDA UDI
7800TN-24 FDA UDI
7800TN-13 FDA UDI
7800TN-22 FDA UDI
3400CP-018 FDA UDI
7800TN-16 FDA UDI
7800TN-12 FDA UDI
3100CP-030 FDA UDI
7800TN-26 FDA UDI
Primary DI / UDI-DI
00724004613652 EUDAMED
00724004621480 EUDAMED
00724004311169 EUDAMED
00724004621534 EUDAMED
00724004321151 EUDAMED
00724004311084 EUDAMED
00724004331075 EUDAMED
00724004311077 EUDAMED
00724004621664 EUDAMED
00724004621510 EUDAMED
00724004621466 EUDAMED
00724004351011 EUDAMED
00724004341159 EUDAMED
00724004621558 EUDAMED
00724004311152 EUDAMED
00724004621527 EUDAMED
00724004311015 EUDAMED
00724004351165 EUDAMED
10724004613659 FDA UDI
10724004321158 FDA UDI
10724004331072 FDA UDI
10724004621524 FDA UDI
10724004621661 FDA UDI
10724004621517 FDA UDI
10724004341156 FDA UDI
10724004621487 FDA UDI
10724004621463 FDA UDI
10724004311159 FDA UDI
10724004621531 FDA UDI
Basic UDI-DI
0724004COFLEXTLCSNGLCALZV EUDAMED
0724004CoFlexTLCSingleYN EUDAMED
0724004CoFlex3F EUDAMED
0724004CoFlexTLCAY EUDAMED
FDA Product Code
KGX FDA UDI
FQM FDA UDI
MHW FDA UDI
EMDN Code
M03040299 ELASTIC SUPPORT BANDAGES - OTHER EUDAMED
M030402020101 ELASTIC SUPPORT BANDAGES, COHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY EUDAMED
GMDN Term
Compression bandaging kit FDA UDI
Pressure bandage, Hevea-latex, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
880.5240 FDA UDI
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 UDIEUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMEDEUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

Yes

EUDAMEDEUDAMED

Prescription Use

Yes

FDA UDIFDA UDI

Over-the-Counter

No

FDA UDIFDA UDI

Convenience Kit

Yes

FDA UDIFDA 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 TLC Single Calamine 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Andover Healthcare Inc.
EUDAMED SRN
US-MF-000035055
Authorised Representative
Advena Limited MT-AR-000000234

Sources (29)

  • EUDAMED 3078fc55-80d3-4d96-9abd-60d63bd51fc7 61 fields · synced Oct 6, 2026
  • FDA UDI 3455912e-d762-4abb-84dc-6718b2d4d7ff 35 fields · synced May 29, 2026
  • FDA UDI 9ffe690f-50e1-4ba4-8b57-35e76ff256a5 35 fields · synced May 29, 2026
  • FDA UDI bbae201a-a518-4464-9eb7-0c12ca5c21c9 35 fields · synced May 30, 2026
  • FDA UDI b04afb9d-9c03-469b-8ed5-4a7385b6996a 35 fields · synced May 30, 2026
  • FDA UDI 4e582cf4-c882-4bf8-830c-cb262f0d1f04 35 fields · synced May 30, 2026
  • FDA UDI 8f438b69-471a-4947-bc28-812b17275744 35 fields · synced May 30, 2026
  • FDA UDI bff4bd19-b5b4-44a8-87f6-a75612991ccb 35 fields · synced May 30, 2026
  • FDA UDI b608fee1-6c28-43e7-bc22-1ef2c019cbef 35 fields · synced May 30, 2026
  • FDA UDI c9601a0d-191b-4995-8532-ef3a30ac6cff 35 fields · synced May 30, 2026
  • FDA UDI 9285087a-b0cb-4b72-886b-3b2e248f65ae 35 fields · synced May 30, 2026
  • FDA UDI 1e2fe003-aa58-4912-a68a-4d8c0bc5cc6f 35 fields · synced May 30, 2026
  • EUDAMED 1ab71546-52db-49e2-8459-9e0d43ac0f51 61 fields · synced Jun 20, 2026
  • EUDAMED b8114b7a-f3ee-4c80-a97c-5d0bc8997d11 61 fields · synced Jul 8, 2026
  • EUDAMED 6115ea08-c0e0-433d-ac9e-b0bdeb3a8099 61 fields · synced Jul 10, 2026
  • EUDAMED 22b0004f-258e-4c09-857c-10e81975938c 61 fields · synced Jul 10, 2026
  • EUDAMED 69cf8b57-bc20-43c2-bebc-4a71bf820b8e 61 fields · synced Jul 11, 2026
  • EUDAMED 4707c1ad-685b-444d-8871-6c3f02779480 61 fields · synced Jul 14, 2026
  • EUDAMED a19d934f-8865-4ca6-a489-50a8ae18daee 61 fields · synced Jul 15, 2026
  • EUDAMED 8df00967-b2a8-4eb6-a561-45eb474fc469 61 fields · synced Jul 15, 2026
  • EUDAMED 8d8df5b7-89e8-4a91-8f51-520880ad49df 61 fields · synced Jul 15, 2026
  • EUDAMED 416d2500-c454-4c12-a3b6-066976215686 61 fields · synced Jul 19, 2026
  • EUDAMED 1455fa2b-69bd-4f7d-be0f-b1680d0cff40 61 fields · synced Jul 19, 2026
  • EUDAMED 26e3284c-f54e-40fd-87af-aab2dc00eee1 61 fields · synced Jul 22, 2026
  • EUDAMED 799445a5-0ad8-446a-b45c-03f350a6920f 61 fields · synced Jul 23, 2026
  • EUDAMED 01a1c07a-146d-4028-ad13-f3085df211d0 61 fields · synced Jul 25, 2026
  • EUDAMED 6cd71570-43bb-42b5-a05d-e51d1000d427 61 fields · synced Jul 26, 2026
  • EUDAMED 6be2e95f-dd14-4b75-9dd5-e3c4967c0cd6 61 fields · synced Jul 27, 2026
  • EUDAMED a7c6e5e1-a97c-4d5e-aa96-20893ca9dc76 61 fields · synced Jul 31, 2026