Identity
- Trade Name
- Skinister Medical Adhesive EUDAMED
- Device Name
- Skinister Medical Adhesive EUDAMED
- Model / Reference
- SA1D-INT-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810049491260 EUDAMED
- Basic UDI-DI
- 081004949ADHESIVEFE EUDAMED
- EMDN Code
- A108008 ADHESIVES FOR ABDOMINAL OSTOMY DEVICES 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
Skinister Medical Adhesive by Delta Molding 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 | 081004949ADHESIVEFE | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Delta Molding LLC
- EUDAMED SRN
- US-MF-000042482
- Authorised Representative
- Freyr Regulatory GmbH DE-AR-000047121
Sources (1)
- EUDAMED c14d8b0d-58c2-4b9f-8600-a1cb7127e89e 61 fields · synced Jun 19, 2026