A Supreme Left Size 12
EUDAMEDFDA UDIClass I (EU MDR)
by Trulife
Identity
- Trade Name
- A Supreme Left Size 12 EUDAMEDA Supreme FDA UDI
- Generic Name
- External breast prosthesis FDA UDI
- Device Name
- Breastcare EUDAMEDA Supreme Left Size 12 FDA UDI
- Model / Reference
- Breastcare EUDAMED503 12L EUDAMEDFDA UDI
- Description
- A Supreme Left Size 12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643293000236 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
Single Use
Yes
Implantable
No
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
A Supreme Left Size 12 by Trulife — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 65f44964-4697-4e97-a57b-464be77aad3f 61 fields · synced Jun 18, 2026
- FDA UDI b99ee2dc-61ce-4a7a-86bd-27a334946a6e 33 fields · synced May 29, 2026