Motiva® SmoothSilk® Round Breast Implant
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- Motiva Implants EUDAMEDMotiva® SmoothSilk® Round Breast Implant FDA UDI
- Generic Name
- Silicone gel-filled breast implant, smooth-surface FDA UDI
- Device Name
- Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi 230 cc FDA UDI
- Model / Reference
- RSD-230+ EUDAMEDFDA UDIMotiva Implants Round SmoothSilk/SilkSurface Plus EUDAMED
- Description
- Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Demi 230 cc FDA UDI
Identifiers
- Catalog Number
- RSD-230+ FDA UDI
- Primary DI / UDI-DI
- 07445161001863 EUDAMEDFDA UDI
- Basic UDI-DI
- 7445161SilkPlusS4 EUDAMED
- PMA Number
- P230005 FDA UDI
- FDA Product Code
- FTR FDA UDI
- EMDN Code
- P0601010201,X020102 EUDAMED
- GMDN Term
- Silicone gel-filled breast implant, smooth-surface FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA UDI
- Regulation Number
- 878.3540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Silicone gel-filled breast implant, smooth-surface
Motiva® SmoothSilk® Round Breast Implant by Establishment Labs S.A. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Silicone gel-filled breast implant, smooth-surface.
- NATRELLE Silicone-Filled Breast Implants — Allergan · Class III
- OPUS Silicone Gel Breast Implant — Sientra, Inc. · Class III
- Natrelle Inspira Cohesive Breast Implants — Allergan · Class III
- MENTOR MemoryGel Breast Implant — Mentor Texas LP · Class III
- OPUS Silicone Gel Breast Implant — Sientra, Inc. · Class III
- MENTOR MemoryGel BOOST Breast Implant — Mentor Texas LP · Class III
- Natrelle Inspira Cohesive Breast Implants — Allergan · Class III
- MENTOR MemoryGel Xtra Breast Implant — Mentor Texas LP · Class III
Cleared under the same submission
P230005 also covers:
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
- Motiva® SmoothSilk® Round Breast Implant — Establishment Labs S.A.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Establishment Labs S.A.
Sources (2)
- FDA UDI 4f330382-219d-4458-9bd9-f3c2c5e070ca 35 fields · synced Oct 7, 2026
- EUDAMED 01f7b52a-e987-473b-b5dd-a9c5b6a51cfc 61 fields · synced Oct 7, 2026