Identity
- Trade Name
- SILSHAPE EUDAMED
- Device Name
- SILSHAPE EUDAMED
- Model / Reference
- SILSHAPE EUDAMEDSH-008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800017100609 EUDAMED
- Basic UDI-DI
- 88000171SH008CJ EUDAMED
- EMDN Code
- Z12010902,Z120623 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
Silshape by shenb Co., Ltd. — Class IIb — 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 | 88000171SH008CJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- SHENB Co., Ltd.
- EUDAMED SRN
- KR-MF-000021619
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 331019dd-5c5c-4c79-90b1-9224de40f62a 61 fields · synced Jul 10, 2026