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Silk Encore Triangle Size 16
EUDAMEDFDA UDIClass I (EU MDR)
Ref 483 16Model Breastcare
by Trulife
Identity
- Trade Name
- Silk Encore Triangle Size 16 EUDAMEDSilk Encore Triangle FDA UDI
- Generic Name
- External breast prosthesis FDA UDI
- Device Name
- Breastcare EUDAMEDSilk Encore Triangle Size 16 FDA UDI
- Model / Reference
- Breastcare EUDAMED483 16 EUDAMEDFDA UDI
- Description
- Silk Encore Triangle Size 16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293020968 EUDAMEDFDA UDI
- Basic UDI-DI
- 00643293Breastcare6Z EUDAMED
- FDA Product Code
- NOJ FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- External breast prosthesis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3800 FDA UDI
- Market of Registration
- Ireland 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silk Encore Triangle Size 16 by Trulife — 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 | 00643293Breastcare6Z | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Trulife
- EUDAMED SRN
- IE-MF-000003108
Sources (2)
- EUDAMED bd826779-4bd0-44e1-8cfc-38c860ccf732 61 fields · synced Jul 27, 2026
- FDA UDI d81bc52f-3b98-479a-875c-8425be68892b 33 fields · synced May 30, 2026