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Dr Max Audimax Ear Spray Aqua Clean 30ml
EUDAMEDClass I (EU MDR)
Ref 3745-2024/03
Identity
- Trade Name
- DR MAX AUDIMAX EAR SPRAY AQUA CLEAN 30ML EUDAMED
- Device Name
- DR MAX AUDIMAX EAR SPRAY AQUA CLEAN 30ML EUDAMED
- Model / Reference
- 3745-2024/03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595566423575 EUDAMED
- Basic UDI-DI
- B-08595566423575 EUDAMED
- EMDN Code
- Q03040299 EAR IRRIGATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dr Max Audimax Ear Spray Aqua Clean 30ml by Društvo za proizvodnju i promet Esensa d.o.o. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08595566423575 | Class I | Active |
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Manufacturer
- Manufacturer
- Društvo za proizvodnju i promet Esensa d.o.o.
- EUDAMED SRN
- RS-MF-000031288
- Authorised Representative
- Salus Cons Kft. HU-AR-000006177
Sources (1)
- EUDAMED 4b1d4e8e-2718-4de7-94de-0e3b6036e171 61 fields · synced Jun 18, 2026