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SoftSil™ - Silicone Adhesive Patch
EUDAMEDFDA UDIClass I (EU MDR)
Ref N745Model SoftSil™
Identity
- Trade Name
- SoftSil™ - Silicone Adhesive Patch EUDAMEDSoftSil™ FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, silicone FDA UDI
- Device Name
- SoftSil™ EUDAMEDSoftSil Silicon Adhesive Patch intended for general use as a medical adhesive. FDA UDI
- Model / Reference
- SoftSil™ EUDAMEDN745 EUDAMEDStandard FDA UDI
- Description
- SoftSil Silicon Adhesive Patch intended for general use as a medical adhesive. FDA UDI
Identifiers
- Catalog Number
- N745 FDA UDI
- Primary DI / UDI-DI
- 10812594011631 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N74500NC EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
- GMDN Term
- Dressing-fixation skin adhesive tape, silicone FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
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
Yes
FDA UDI
SoftSil™ - Silicone Adhesive Patch by Neotech Products 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 | 081259401N74500NC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neotech Products LLC
- EUDAMED SRN
- US-MF-000001895
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 609f6b6b-16be-4ae5-a24e-11a405e0745f 61 fields · synced Jun 18, 2026
- FDA UDI 404d201e-e529-4005-8556-e7aef0a6c85f 34 fields · synced May 30, 2026