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Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd…

FDA 510(k)EUDAMED

U (US FDA 510(k))

510(k) K083133Ref 3744WH-08Model POWERFLEX AFD

by Andover Healthcare Inc.

Identity

Trade Name
POWERFLEX AFD EUDAMED
Device Name
COFLEX EUDAMED
Model / Reference
POWERFLEX AFD EUDAMED
3744WH-08 EUDAMED

Identifiers

Primary DI / UDI-DI
00724004607637 EUDAMED
Basic UDI-DI
0724004PowerFlexAFD7V EUDAMED
510(k) Number
K083133 FDA 510(k)
FDA Product Code
FRO FDA 510(k)
EMDN Code
M030402020101 ELASTIC SUPPORT BANDAGES, COHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY EUDAMED

Classification

Device Class
Class I EUDAMED
U FDA 510(k)
Market of Registration
Denmark EUDAMED
Advisory Committee
Unknown FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

Yes

EUDAMED

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

Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd… by Andover Healthcare Inc. — U — MDR, FDA_510K — listed in FDA 510(k), EUDAMED

Manufacturer's product page: CoFlex® AFD

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Andover Healthcare Inc.
FDA Applicant
Andover Healthcare, Inc.

Sources (2)

  • FDA 510(k) K083133 24 fields · synced Oct 6, 2026
  • EUDAMED d8100e4c-767a-4242-83bd-f1ecf0f53b97 61 fields · synced Jul 10, 2026