Identity
- Trade Name
- Eureko Mouth Spray EUDAMED
- Device Name
- Mucoadhesive Gel EUDAMED
- Model / Reference
- EMS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 8857126051070 EUDAMED
- Basic UDI-DI
- 4718037NANOMUCOSAAN EUDAMED
- Direct Marketing DI
- 8857126051070 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Eureko Mouth Spray by NanoSigma Biotech. 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 | 4718037NANOMUCOSAAN | Class I | Active |
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Manufacturer
- Manufacturer
- NanoSigma Biotech. Co., Ltd.
- EUDAMED SRN
- TW-MF-000023025
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d93f0978-1a5a-45c9-98d8-0a7eb7032a79 61 fields · synced Jun 18, 2026