Identity
- Trade Name
- KemaSerum EUDAMED
- Device Name
- Scar reduction dressings EUDAMED
- Model / Reference
- SERSID30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06221329002511 EUDAMED
- Basic UDI-DI
- 62220238ScarRR EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
KemaSerum by Pharmaplast — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 62220238ScarRR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pharmaplast
- EUDAMED SRN
- EG-MF-000004501
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (1)
- EUDAMED 2a1840de-12a3-4903-96f3-599e9658054c 61 fields · synced Jul 25, 2026