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Prontex
EUDAMEDClass IIa (EU MDR)
Ref SAF-16809Model 40-3001/ 780349 / 40-3003 / 780351 / 40-3014 / 752825 / 40-3070 / 2003043 / 40-3071 / 2003041 / 40-3075 / 2003042 / 40-4013 / 752892 / 40-6001 / 781429 / 40-6003 / 781430 / 40-6013 / 781431 / 75-1623 / 781623 / 75-4331 / 754331 / 75-4378 / 754378 Ref SAF-16801Ref SAF-16805
by Aso Llc
Identity
- Trade Name
- PRONTEX EUDAMED
- Device Name
- Non-Sterile Hydrocolloid Bandages EUDAMED
- Model / Reference
- 40-3001/ 780349 / 40-3003 / 780351 / 40-3014 / 752825 / 40-3070 / 2003043 / 40-3071 / 2003041 / 40-3075 / 2003042 / 40-4013 / 752892 / 40-6001 / 781429 / 40-6003 / 781430 / 40-6013 / 781431 / 75-1623 / 781623 / 75-4331 / 754331 / 75-4378 / 754378 EUDAMEDSAF-16809 EUDAMEDSAF-16801 EUDAMEDSAF-16805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052675160116 EUDAMED08052675160529 EUDAMED08052675160093 EUDAMED
- Basic UDI-DI
- 0017276M226M3 EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly 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
Prontex by Aso LLC — Class IIa — 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 | 0017276M226M3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aso Llc
- EUDAMED SRN
- US-MF-000008641
- Authorised Representative
- Aso Europe BV NL-AR-000004377
Sources (3)
- EUDAMED 4e4f8d1f-9424-472e-9014-c16397c79582 61 fields · synced Jul 13, 2026
- EUDAMED 913a3124-28b8-4eff-9e72-917b30e262bb 61 fields · synced May 18, 2026
- EUDAMED c95bf017-ae9c-46d7-89ed-6f53daaedb8a 61 fields · synced May 19, 2026