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Herpatch

EUDAMED

Class I (EU MDR)

Ref 4,8 g

by Sylphar nv

Identity

Trade Name
Herpatch EUDAMED
Device Name
Herpatch Cold Sore Prevention EUDAMED
Model / Reference
4,8 g EUDAMED

Identifiers

Primary DI / UDI-DI
05425012531048 EUDAMED
Basic UDI-DI
542501253HPPDK EUDAMED
EMDN Code
M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Spain 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

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Herpatch by Sylphar nv — 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

Manufacturer
Sylphar nv
EUDAMED SRN
BE-MF-000000732

Sources (2)

  • EUDAMED 7ca2eda5-c2ca-42c7-8c0b-0f4eed1ff60a 61 fields · synced Jun 18, 2026
  • EUDAMED 7ca2eda5-c2ca-42c7-8c0b-0f4eed1ff60a-1 61 fields · synced Jun 9, 2026