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Breastform Cover Left Size 06 (478/ 482)
EUDAMEDFDA UDIClass I (EU MDR)
Ref N007L06Model Breastcare
by Trulife
Identity
- Trade Name
- Breastform Cover Left Size 06 (478/ 482) EUDAMEDTrulife FDA UDI
- Generic Name
- External breast prosthesis FDA UDI
- Device Name
- Breastcare EUDAMEDBreast Prothesis Cover (Silk Xtend) Left Size 6 FDA UDI
- Model / Reference
- Breastcare EUDAMEDN007L06 EUDAMEDFDA UDI
- Description
- Breast Prothesis Cover (Silk Xtend) Left Size 6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293030561 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 Left Size 06 (478/ 482) 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 c98f5077-54d3-4124-b248-8446f4f2c888 61 fields · synced Jul 16, 2026
- FDA UDI 1155cc2e-fac8-4357-9804-8a625331bd2e 33 fields · synced May 30, 2026