Identity
- Trade Name
- CARELEAVES WATERPROOF EUDAMED
- Device Name
- CARELEAVES WATERPROOF EUDAMED
- Model / Reference
- CLB20M-FRMJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664789001053 EUDAMED
- Basic UDI-DI
- 3664789CLB_8S 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 Waterproof 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 | 3664789CLB_8S | 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 82befe1d-424d-4d7d-a338-73e85b0e8aa7 61 fields · synced Jun 19, 2026