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DGDerm
EUDAMEDClass I (EU MDR)
Ref BF028Model 28 mlRef Scar Gel 15grModel Scar gel
Identity
- Trade Name
- DGDerm EUDAMED
- Device Name
- Barrier Film EUDAMEDScar Gel EUDAMED
- Model / Reference
- 28 ml EUDAMEDBF028 EUDAMEDScar gel EUDAMEDScar Gel 15gr EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06262298001266 EUDAMED06262298000344 EUDAMED
- Basic UDI-DI
- 062622980BarrierFilmV8 EUDAMED062622980scargelYX EUDAMED
- EMDN Code
- A108004 PROTECTIVE FILMS / SPRAYS FOR PERISTOMAL SKIN EUDAMEDZ12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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
DGDerm by Dadeh Gostaran Dena — Class I — 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 | 062622980BarrierFilmV8 | Class I | Active |
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Manufacturer
- Manufacturer
- Dadeh Gostaran Dena
- EUDAMED SRN
- IR-MF-000038532
- Authorised Representative
- Eska Diagnostics Kft HU-AR-000037211
Sources (2)
- EUDAMED 7e3cbc40-0540-4767-b379-a3316ef58b8e 61 fields · synced Jul 9, 2026
- EUDAMED 31796f12-8184-496e-a280-bd47364737ef 61 fields · synced May 18, 2026