Identity
- Trade Name
- VIVALINE EUDAMED
- Device Name
- VIVALINE EUDAMED
- Model / Reference
- VIVALINE EUDAMEDSH-009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800017100562 EUDAMED
- Basic UDI-DI
- 88000171SH009CL EUDAMED
- EMDN Code
- Z120622 MUSCLE STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa 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
Vivaline by shenb Co., Ltd. — Class IIa — 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 | 88000171SH009CL | Class IIa | 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 7e312dcf-dc88-46fb-ad04-563f5b915589 61 fields · synced Aug 1, 2026