NewGel+E Advanced Silicone Gel for Scars
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- NewGel+E EUDAMEDNewGel+E Advanced Silicone Gel for Scars FDA UDI
- Generic Name
- Scar-management dressing, single-use FDA UDI
- Device Name
- NewGel+E Silicone Gel EUDAMEDNGO-800 NewGel+E Silicone Gel, 0.5 oz. (15 gram), 1 tube/package FDA UDI
- Model / Reference
- NGO-800 EUDAMEDFDA UDI
- Description
- NGO-800 NewGel+E Silicone Gel, 0.5 oz. (15 gram), 1 tube/package FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816465020305 EUDAMEDFDA UDI
- Basic UDI-DI
- 081646502NGEF7 EUDAMED
- FDA Product Code
- MDA FDA UDI
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
- GMDN Term
- Scar-management dressing, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4025 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Scar-management dressing, single-use
NewGel+E Advanced Silicone Gel for Scars by Newmedical Technology, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Scar-management dressing, single-use.
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- NEW BEGINNINGS® GELSHAPES® — Pmt Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Newmedical Technology, Inc.
Sources (2)
- FDA UDI cd351f45-1d48-4d76-b6a9-6ae7df25ccea 35 fields · synced Jul 11, 2026
- EUDAMED a9977c6b-772f-473e-9397-6bcc36c8a3ce 61 fields · synced Jul 11, 2026