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Silk Flex Darktone Size 14
EUDAMEDClass I (EU MDR)
Ref 487 14Model Breastcare
by Trulife
Identity
- Trade Name
- Silk Flex Darktone Size 14 EUDAMED
- Device Name
- Breastcare EUDAMED
- Model / Reference
- Breastcare EUDAMED487 14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00643293033678 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
Category: Device sterilization/disinfection container, reusable
Silk Flex Darktone Size 14 by Trulife — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 f1f1b02b-5e42-4f1c-a208-e1b8c82e1d12 61 fields · synced Jul 11, 2026