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Careleaves
EUDAMEDClass I (EU MDR)
Ref CL363-FRMJRef CL10T-FRMJRef CL7B-FRMJRef CL30M-FRMJ
Identity
- Trade Name
- CARELEAVES EUDAMED
- Device Name
- CARELEAVES EUDAMED
- Model / Reference
- CL363-FRMJ EUDAMEDCL10T-FRMJ EUDAMEDCL7B-FRMJ EUDAMEDCL30M-FRMJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664789000957 EUDAMED03664789000681 EUDAMED03664789000674 EUDAMED03664789000667 EUDAMED
- Basic UDI-DI
- 3664789CL_JV EUDAMED
- Unit of Use DI
- 83664789000687 EUDAMED83664789000670 EUDAMED83664789000663 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 (4)
- EUDAMED 7bea7e1c-dd5e-4d50-b0a1-53a3e957b7ba 61 fields · synced Sep 18, 2026
- EUDAMED 5b5f4d4c-8a48-4783-bd37-82f19db15a09 61 fields · synced May 17, 2026
- EUDAMED 46d67483-7cf7-48bf-843f-2db4c5d3338f 61 fields · synced May 18, 2026
- EUDAMED 64caec3b-6033-4d8d-ac35-7c4e744ffe49 61 fields · synced May 19, 2026