exofin Fusion Skin Closure System 22cm

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref EF70460CEModel EF70422CERef EF70430CE

by Chemence Medical Inc.

Identity

Device Name: exofin Fusion Skin Closure System 22cm EUDAMED
Model / Reference: EF70422CE EUDAMED
EF70460CE EUDAMED
EF70430CE EUDAMED

Identifiers

Primary DI / UDI-DI: 00854137001566 EUDAMED
00854137001412 EUDAMED
Basic UDI-DI: 854137001OMDJZ EUDAMED
Direct Marketing DI: 00854137001566 EUDAMED
00854137001412 EUDAMED
EMDN Code: H900199 TISSUE ADHESIVES - OTHER EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Poland EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

exofin Fusion Skin Closure System 22cm by Chemence Medical Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K191461	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K171442	Class IIa	Active
EUDAMED	European Union	CE/MDR	854137001OMDJZ	Class IIa	Active

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Manufacturer

Manufacturer: Chemence Medical Inc.
EUDAMED SRN: US-MF-000000888
Authorised Representative: Atlantico Systems, Ltd. IE-AR-000000208

Sources (3)

EUDAMED e62f7ab5-945c-4194-ab8b-f6c01fb0da43 61 fields · synced Sep 18, 2026
EUDAMED 431c5811-f910-4ddd-9ee6-5344bd84d6c2 61 fields · synced May 18, 2026
FDA 510(k) K191461 1 fields · synced May 18, 2026