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Protix
EUDAMEDClass I (EU MDR)
Ref GU130SModel GUANTO IN NITRILERef GUN215LRef GU130LRef GUN215XLRef GU130XLRef GUN215S
Identity
- Trade Name
- PROTIX EUDAMEDPROTIX BLACK EUDAMED
- Device Name
- GUANTO MONOUSO IN NITRILE SENZA POLVERE EUDAMED
- Model / Reference
- GUANTO IN NITRILE EUDAMEDGU130S EUDAMEDGUN215L EUDAMEDGU130L EUDAMEDGUN215XL EUDAMEDGU130XL EUDAMEDGUN215S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08024151807259 EUDAMED08024151813151 EUDAMED08024151807297 EUDAMED08024151813168 EUDAMED08024151807310 EUDAMED08024151813137 EUDAMED
- Basic UDI-DI
- 8024151GUNSYY EUDAMED
- Direct Marketing DI
- 08024151807259 EUDAMED08024151813151 EUDAMED08024151807297 EUDAMED08024151813168 EUDAMED08024151807310 EUDAMED08024151813137 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 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 (6)
- EUDAMED 88043b05-6b1e-49cd-944a-565aa97925d6 61 fields · synced Jul 26, 2026
- EUDAMED 0b47dc0f-a1d6-482a-8671-a4eb9ec1d4e6 61 fields · synced May 17, 2026
- EUDAMED 232f7883-465b-4ec0-9846-28ea0849f58a 61 fields · synced May 17, 2026
- EUDAMED f338d731-0c0d-490d-9610-6ca5e949058c 61 fields · synced May 17, 2026
- EUDAMED 5448e305-470b-418e-8585-ee3b32862ca9 61 fields · synced May 18, 2026
- EUDAMED 14a6cf03-32b3-42e0-bac2-f78029cec79b 61 fields · synced May 18, 2026