Sterile Skin Markers under Class 1s

by Viscot Medical LLC 38 variants

Ref 1416SModel 1400

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number08481060VIS500F9 Basic UDI-DI 00848106000308UDI-DI	Date8 Jun 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Sterile Skin Markers under Class 1s
Model / Reference: 1400, 1416S

Primary DI / UDI-DI: 00848106000308
Basic UDI-DI: 08481060VIS500F9
EMDN Code: V9004 Skin marking dermographic pencils and pens

Device Class: Class I
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: US-MF-000029821
Authorised representative: MedEnvoy Global BV NL-AR-000024028

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See all devices from Viscot Medical LLC →

Properties

Sterile

Other properties (12)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No