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Silk Flex Size 5
EUDAMEDFDA UDIClass I (EU MDR)
Ref 477 05Model Breastcare
by Trulife
Identity
- Trade Name
- Silk Flex Size 5 EUDAMEDSilk Flex FDA UDI
- Generic Name
- External breast prosthesis FDA UDI
- Device Name
- Breastcare EUDAMEDSilk Flex Size 5 FDA UDI
- Model / Reference
- Breastcare EUDAMED477 05 EUDAMEDFDA UDI
- Description
- Silk Flex Size 5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293016565 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 Flex Size 5 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 50bc2cb7-000e-49e0-964b-f506d96b1a1f 61 fields · synced Jun 19, 2026
- FDA UDI 53d8ce05-25d1-4aea-a0a4-1df7978d428e 33 fields · synced May 30, 2026