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CoFlex TLC Zinc

EUDAMED

Class I (EU MDR)

Ref 8830UBZ-TN-INTLModel CoFlex TLC Zinc

by Andover Healthcare Inc.

Identity

Trade Name
CoFlex TLC Zinc EUDAMED
Device Name
COFLEX TLC EUDAMED
Model / Reference
CoFlex TLC Zinc EUDAMED
8830UBZ-TN-INTL EUDAMED

Identifiers

Primary DI / UDI-DI
00724004611856 EUDAMED
Basic UDI-DI
0724004CoFlexTLCZincAH EUDAMED
EMDN Code
M03040299 ELASTIC SUPPORT BANDAGES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Denmark EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

CoFlex TLC Zinc by Andover Healthcare Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
US-MF-000035055
Authorised Representative
Advena Limited MT-AR-000000234

Sources (1)

  • EUDAMED 666f660b-94d3-412d-8fff-83eb111f6cdb 61 fields · synced Jun 19, 2026