Identity
- Trade Name
- Hi-Mupro Oral Gel EUDAMED
- Device Name
- Mucoadhesive Gel EUDAMED
- Model / Reference
- HX-OG120 EUDAMEDHX-OS30 EUDAMEDHX-OS12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769861899 EUDAMED04711769860052 EUDAMED04711769861875 EUDAMED
- Basic UDI-DI
- 4718037NANOMUCOSAAN EUDAMED
- Direct Marketing DI
- 04711769861899 EUDAMED04711769860052 EUDAMED04711769861875 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Hi-Mupro Oral Gel by NanoSigma Biotech. Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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 (3)
- EUDAMED bd070e02-6374-45ac-b476-c75a2612b13d 61 fields · synced Jul 24, 2026
- EUDAMED 2864a6df-bb68-4398-bc22-928465ec6eb2 61 fields · synced May 17, 2026
- EUDAMED 6b9686eb-8a80-4eca-804b-bfee988e727c 61 fields · synced May 19, 2026