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Breastform Cover Size 15 (102/483)
EUDAMEDFDA UDIClass I (EU MDR)
Ref D00115Model Breastcare
by Trulife
Identity
- Trade Name
- Breastform Cover Size 15 (102/483) EUDAMEDTrulife FDA UDI
- Generic Name
- External breast prosthesis FDA UDI
- Device Name
- Breastcare EUDAMEDBreast Prothesis Cover (Impressions II Encore / Silk Encore Triangle) Size 15 FDA UDI
- Model / Reference
- Breastcare EUDAMEDD00115 EUDAMEDFDA UDI
- Description
- Breast Prothesis Cover (Impressions II Encore / Silk Encore Triangle) Size 15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293030936 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
Breastform Cover Size 15 (102/483) 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 e7b97883-8728-44de-aa3b-4b204134067b 61 fields · synced Jun 18, 2026
- FDA UDI 51ef57b3-4ce1-447f-ae90-963681276ff7 33 fields · synced May 30, 2026