Identity
- Trade Name
- SKINERGATE EUDAMED
- Device Name
- SKINERGATE EUDAMED
- Model / Reference
- SG12 EUDAMEDSG50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987167097674 EUDAMED14987167097698 EUDAMED
- Basic UDI-DI
- 4987167SG_P7 EUDAMED
- EMDN Code
- M050101 PLASTERS ON SPOOLS (ROLLS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Skinergate 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 | 4987167SG_P7 | 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 (2)
- EUDAMED 5bac1e01-dede-46d9-bfc8-00770980aaab 61 fields · synced Jul 29, 2026
- EUDAMED 33ef8a42-2cec-4407-969d-11d86e70825d 61 fields · synced May 19, 2026