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Sensi Nitrix Plus
EUDAMEDClass I (EU MDR)
Ref GU134XSModel GUANTO IN NITRILERef GU134SRef GU134XLRef GU134M
Identity
- Trade Name
- SENSI NITRIX PLUS EUDAMED
- Device Name
- GUANTO MONOUSO IN NITRILE SENZA POLVERE EUDAMED
- Model / Reference
- GUANTO IN NITRILE EUDAMEDGU134XS EUDAMEDGU134S EUDAMEDGU134XL EUDAMEDGU134M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08024151810808 EUDAMED08024151810815 EUDAMED08024151810846 EUDAMED08024151810822 EUDAMED
- Basic UDI-DI
- 8024151GUNSYY EUDAMED
- Direct Marketing DI
- 08024151810808 EUDAMED08024151810815 EUDAMED08024151810846 EUDAMED08024151810822 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Sensi Nitrix Plus by Bericah S.p.A. — 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 | 8024151GUNSYY | Class I | Active |
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Manufacturer
- Manufacturer
- Bericah S.p.A.
- EUDAMED SRN
- IT-MF-000007397
Sources (4)
- EUDAMED eb9efba2-086b-4cc1-a514-236ae5cff43d 61 fields · synced Jul 30, 2026
- EUDAMED 7c421f98-2ded-4e7c-898b-db0193064653 61 fields · synced May 18, 2026
- EUDAMED 2ae6455c-fb66-4516-a04d-250112cf8c28 61 fields · synced May 18, 2026
- EUDAMED ff9963c8-baee-417e-a9bb-4d49eef6c29d 61 fields · synced May 19, 2026