Identity
- Trade Name
- OPRO EUDAMED
- Device Name
- OPRO Cleaning Pod EUDAMED
- Model / Reference
- OPR-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060960871241 EUDAMED
- Basic UDI-DI
- 506014357DentalPodXC EUDAMED
- Secondary DI
- 5060960871244 EUDAMED
- EMDN Code
- V0799 PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Opro by OPRO International Ltd — 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 | 506014357DentalPodXC | Class I | Active |
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Manufacturer
- Manufacturer
- OPRO International Ltd
- EUDAMED SRN
- GB-MF-000004793
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 715261f0-5289-4442-8a77-c6420e8212c1 61 fields · synced Oct 6, 2026