Identity
- Trade Name
- EZ Fan+ EUDAMEDEZ Fan EUDAMED
- Device Name
- Sterile, single use instrument for the delivery of silicone gel implants EUDAMED
- Model / Reference
- REF_01KRP EUDAMEDREF_01KR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800071700449 EUDAMED08800071700005 EUDAMED
- Basic UDI-DI
- 88000717REF_01KRPA6 EUDAMED88000717REF_01KRV2 EUDAMED
- EMDN Code
- P0680 BREAST IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
Yes
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
EZ Fan+ by Kims Med 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 | 88000717REF_01KRPA6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kims Med Co., Ltd.
- EUDAMED SRN
- KR-MF-000022749
- Authorised Representative
- Specculo Limited MT-AR-000034988
Sources (2)
- EUDAMED a782faf0-1e7e-4c21-9444-399fa4baf23e 61 fields · synced Jul 21, 2026
- EUDAMED f6e3ce94-a011-457d-9b32-a1154640e936 61 fields · synced May 19, 2026