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Silk Flex Darktone Size 11
EUDAMEDClass I (EU MDR)
Ref 487 11Model Breastcare
by Trulife
Identity
- Trade Name
- Silk Flex Darktone Size 11 EUDAMED
- Device Name
- Breastcare EUDAMED
- Model / Reference
- Breastcare EUDAMED487 11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00643293033647 EUDAMED
- Basic UDI-DI
- 00643293Breastcare6Z EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Silk Flex Darktone Size 11 by Trulife — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00643293Breastcare6Z | Class I | Active |
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Manufacturer
- Manufacturer
- Trulife
- EUDAMED SRN
- IE-MF-000003108
Sources (1)
- EUDAMED 50ba3369-b3ce-4af2-a1df-ce598e160cf7 61 fields · synced Jun 19, 2026