Identity
- Trade Name
- PROTIX BLACK EUDAMED
- Device Name
- GUANTO MONOUSO IN NITRILE SENZA POLVERE EUDAMED
- Model / Reference
- GUANTO IN NITRILE EUDAMEDGUN215M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08024151813144 EUDAMED
- Basic UDI-DI
- 8024151GUNSYY EUDAMED
- Direct Marketing DI
- 08024151813144 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
Protix Black 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 (1)
- EUDAMED bf068cb7-db42-496a-bc43-41e09dfa2a17 61 fields · synced Jun 19, 2026