← Back to catalogue
Silk Flex Darktone Size 05
EUDAMEDClass I (EU MDR)
Ref 487 05Model Breastcare
by Trulife
Identity
- Trade Name
- Silk Flex Darktone Size 05 EUDAMED
- Device Name
- Breastcare EUDAMED
- Model / Reference
- Breastcare EUDAMED487 05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00643293033586 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 05 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trulife
- EUDAMED SRN
- IE-MF-000003108
Sources (1)
- EUDAMED fa4b4716-5b92-4fe9-a762-fe90d2f2d262 61 fields · synced Jul 19, 2026