Identity
- Trade Name
- Healena EUDAMED
- Device Name
- Healena EUDAMED
- Model / Reference
- GCA-HL-ST-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700469701193 EUDAMED
- Basic UDI-DI
- 037004697F3010NJ EUDAMED
- Direct Marketing DI
- 03700469701193 EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Healena by Eurosilicone Sas — 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 | 037004697F3010NJ | Class I | Active |
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Manufacturer
- Manufacturer
- Eurosilicone Sas
- EUDAMED SRN
- FR-MF-000008947
Sources (1)
- EUDAMED 25606be8-7b7f-4b46-a17e-807112ab3c7c 61 fields · synced Jun 18, 2026