Identity
- Trade Name
- Herpatch EUDAMED
- Device Name
- Herpatch Mouth Ulcer Gel EUDAMEDHerpatch Cold Sore Serum EUDAMED
- Model / Reference
- 10 ml EUDAMED5 ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05425012531901 EUDAMED05425012531017 EUDAMED
- Basic UDI-DI
- B-05425012531901 EUDAMEDB-05425012531017 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Herpatch by Sylphar nv — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05425012531901 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sylphar nv
- EUDAMED SRN
- BE-MF-000000732
Sources (2)
- EUDAMED 051318e2-c25c-4638-84c3-f255ff8db7dd 61 fields · synced Jul 29, 2026
- EUDAMED ced225f9-18ab-42ce-8174-3f252f03cfbc 61 fields · synced May 17, 2026