Identity
- Trade Name
- CARELEAVES EUDAMED
- Device Name
- CARELEAVES EUDAMED
- Model / Reference
- SMPCL- FRMJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664789001305 EUDAMED
- Basic UDI-DI
- 3664789CL_JV EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Careleaves by Nichiban Co., Ltd. — 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 | 3664789CL_JV | Class I | Active |
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Manufacturer
- Manufacturer
- Nichiban Co., Ltd.
- EUDAMED SRN
- JP-MF-000004197
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED e8109112-a703-4fc7-b732-ed502f0d1587 61 fields · synced Jun 17, 2026