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NanoSigma Oral Gel
EUDAMEDClass I (EU MDR)
Ref SPEC-OG-01Model NSOGRef NSOG-0029
Identity
- Trade Name
- NanoSigma Oral Gel EUDAMEDORAL GEL EUDAMED
- Device Name
- ORAL GEL EUDAMEDMucoadhesive Gel EUDAMED
- Model / Reference
- NSOG EUDAMEDSPEC-OG-01 EUDAMEDNSOG-0029 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04718037840075 EUDAMED04718037842116 EUDAMED04718037842130 EUDAMED
- Basic UDI-DI
- B-04718037840075 EUDAMED4718037NANOMUCOSAAN EUDAMEDB-04718037842130 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania 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
NanoSigma Oral Gel by NanoSigma Biotech. Co., Ltd. — Class I — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04718037840075 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04718037840075 | 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 ced3d6ce-cfde-4c7c-8aaf-b01221535875 61 fields · synced Aug 1, 2026
- EUDAMED cb1b702c-dd09-41c3-af41-21d8c27d0614 61 fields · synced May 18, 2026
- EUDAMED ea686b54-4420-4315-9288-854c11cec6c3 61 fields · synced May 19, 2026