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Skinister Medical Adhesive
EUDAMEDFDA UDIClass I (EU MDR)
Ref SA4SModel SA2SRef SA4S-INT-RRef SA2S-INT-ERef SA2S-INT-RRef SA1D-INT-R
Identity
- Trade Name
- Skinister Medical Adhesive EUDAMEDSkinister Medical EUDAMEDFDA UDI
- Generic Name
- Skin surface device adhesive FDA UDI
- Device Name
- Skinister Medical Adhesive EUDAMEDSilicone pressure sensitive adhesive in hexamethyldisiloxane. 4oz bottle with spray top. FDA UDI
- Model / Reference
- SA2S EUDAMEDSA4S EUDAMEDFDA UDISA4S-INT-R EUDAMEDSA2S-INT-E EUDAMEDSA2S-INT-R EUDAMEDSA1D-INT-R EUDAMED
- Description
- Silicone pressure sensitive adhesive in hexamethyldisiloxane. 4oz bottle with spray top. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810049490645 EUDAMEDFDA UDI00810049491314 EUDAMED00810049491291 EUDAMED00810049491284 EUDAMED00810049491253 EUDAMED
- 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 EUDAMEDFrance 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 Adhesive 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 (6)
- EUDAMED 2ee67d46-6414-427f-95c3-7d60feb4998b 61 fields · synced Jul 28, 2026
- FDA UDI c087a09d-16aa-424b-84b5-192eecd346b5 35 fields · synced May 29, 2026
- EUDAMED 98f99cd0-36d8-4f80-a62f-af4475b1bbf0 61 fields · synced Jul 11, 2026
- EUDAMED 8c87f79d-56fe-4ad9-b869-d13145b8d71a 61 fields · synced Jul 23, 2026
- EUDAMED eced1ff5-1f6a-4cfd-8d16-a9c4131fc054 61 fields · synced Jul 25, 2026
- EUDAMED 6431f55f-92fc-4e54-84e3-98a4f10c9fff 61 fields · synced Jul 28, 2026