Identity
- Trade Name
- BREASTSHELLSET EUDAMED
- Device Name
- SCF157 ISIS COMFORT BREAST SHELL SET EUDAMED
- Model / Reference
- SCF157/02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05012909005647 EUDAMED
- Basic UDI-DI
- 8710103BM781JY EUDAMED
- EMDN Code
- U1003 PUERPERIUM DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Breastshellset by Philips Consumer Lifestyle B.V. — 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 | 8710103BM781JY | Class I | Active |
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Manufacturer
- Manufacturer
- Philips Consumer Lifestyle B.V.
- EUDAMED SRN
- NL-MF-000001693
Sources (1)
- EUDAMED 6c96b9bc-e457-40df-a6a7-5ff17ef8859b 61 fields · synced Sep 18, 2026