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Sensitop High Risk
EUDAMEDClass I (EU MDR)
Ref 42587Model LATEX GLOVERef 42585Ref 42588
Identity
- Trade Name
- SENSITOP HIGH RISK EUDAMED
- Device Name
- GUANTO MONOUSO IN LATTICE SENZA POLVERE NON STERILE EUDAMED
- Model / Reference
- LATEX GLOVE EUDAMED42587 EUDAMED42585 EUDAMED42588 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08024151425873 EUDAMED08024151425859 EUDAMED08024151425880 EUDAMED
- Basic UDI-DI
- 8024151GULSYS EUDAMED
- Direct Marketing DI
- 08024151425873 EUDAMED08024151425859 EUDAMED08024151425880 EUDAMED
- EMDN Code
- T010201 LATEX 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
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sensitop High Risk 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 | 8024151GULSYS | Class I | Active |
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Manufacturer
- Manufacturer
- Bericah S.p.A.
- EUDAMED SRN
- IT-MF-000007397
Sources (3)
- EUDAMED 80665859-454f-490d-bd84-681b653701f7 61 fields · synced Jul 15, 2026
- EUDAMED a491108a-436a-44fc-afd0-c8f8e25d309a 61 fields · synced May 17, 2026
- EUDAMED c0b705d4-750e-4790-8f5a-6f985869e56a 61 fields · synced May 18, 2026