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Diacore
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref High-frequency electromagnetic stimulatorModel DIACORE
Identity
- Trade Name
- DIACORE EUDAMED
- Device Name
- DIACORE EUDAMED
- Model / Reference
- DIACORE EUDAMEDHigh-frequency electromagnetic stimulator EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800017101361 EUDAMED
- Basic UDI-DI
- 88000171SH016CH 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
Diacore by shenb Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253926 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000171SH016CH | 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 (2)
- EUDAMED 0fd8308d-b226-437f-af5c-6ee3ec9b510c 61 fields · synced Jun 18, 2026
- FDA 510(k) K253926 1 fields · synced May 18, 2026