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Prodonto
EUDAMEDClass I (EU MDR)
Ref PROFT0001BLURef PROFT0001BIRef PROFT0001VEFRef PROB00001RRef PROFT0001LILRef PROB00001XFRef PROFT0001AR
Identity
- Trade Name
- PRODONTO EUDAMED
- Device Name
- FACE MASKS EUDAMEDMICRO APPLICATORS EUDAMED
- Model / Reference
- PROFT0001BLU EUDAMEDPROFT0001BI EUDAMEDPROFT0001VEF EUDAMEDPROB00001R EUDAMEDPROFT0001LIL EUDAMEDPROB00001XF EUDAMEDPROFT0001AR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476624309 EUDAMED04250476624323 EUDAMED04250476624293 EUDAMED04250476624873 EUDAMED04250476624262 EUDAMED04250476624903 EUDAMED04250476624279 EUDAMED
- Basic UDI-DI
- 42504766FAMTD EUDAMED42504766MICUL EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMEDQ019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE 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
Prodonto by Akzenta International SA — 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 | 42504766FAMTD | Class I | Active |
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Manufacturer
- Manufacturer
- Akzenta International SA
- EUDAMED SRN
- CH-MF-000036434
- Authorised Representative
- IQX GmbH AT-AR-000016713
Sources (7)
- EUDAMED 7412c4f4-a685-4e56-9042-14e7e45a69b8 61 fields · synced Oct 6, 2026
- EUDAMED 986429ea-abe9-40e3-b9a9-81e0ccba60a7 61 fields · synced May 17, 2026
- EUDAMED 8feabcc7-0a7f-4306-9b06-15d378d9eec1 61 fields · synced May 17, 2026
- EUDAMED d67d7566-50f4-4740-b6c0-cee70ca20751 61 fields · synced May 17, 2026
- EUDAMED 117411c9-251d-4b84-8e44-8d86e87884c5 61 fields · synced May 18, 2026
- EUDAMED 522bafca-54e2-46da-add0-5ba618bf24bb 61 fields · synced May 18, 2026
- EUDAMED 6484f49b-9074-4951-a1db-39a3b30cc69b 61 fields · synced May 18, 2026