Identity
- Trade Name
- Skinister Medical EUDAMEDFDA UDI
- Generic Name
- Skin surface device adhesive FDA UDI
- Device Name
- Skinister Medical Adhesive EUDAMEDSilicone pressure sensitive adhesive in hexamethyldisiloxane. 1oz bottle with dropper top. FDA UDI
- Model / Reference
- SA2S EUDAMEDSA1D EUDAMEDFDA UDI
- Description
- Silicone pressure sensitive adhesive in hexamethyldisiloxane. 1oz bottle with dropper top. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810049490669 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004949ADHESIVEFE EUDAMED
- FDA Product Code
- GBJ FDA UDI
- EMDN Code
- A108008 ADHESIVES FOR ABDOMINAL OSTOMY DEVICES EUDAMED
- GMDN Term
- Skin surface device adhesive FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3750 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Skinister Medical by Delta Molding LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081004949ADHESIVEFE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Delta Molding LLC
- EUDAMED SRN
- US-MF-000042482
- Authorised Representative
- Freyr Life Sciences GmbH DE-AR-000021795
Sources (2)
- EUDAMED 4596fcd1-7a17-4165-bcc7-0fa7bd536e70 61 fields · synced Jun 6, 2026
- FDA UDI 64cb266f-27c1-4134-9edf-38c4d1f702e5 35 fields · synced May 30, 2026