Identity
- Trade Name
- Sili Pack Gel ioox EUDAMED
- Device Name
- Silicone Gel Sheeting EUDAMED
- Model / Reference
- FDG-I146 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00852260000142 EUDAMED
- Basic UDI-DI
- 0850014883BTD001PP EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Sili Pack Gel ioox by Biodermis Llc — 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 | 0850014883BTD001PP | Class I | Active |
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Manufacturer
- Manufacturer
- Biodermis Llc
- EUDAMED SRN
- US-MF-000010640
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED df3576fc-2298-4c8b-b32e-e82a6b7c7e1c 61 fields · synced Jun 18, 2026