Identity
- Trade Name
- MARISOL HYPERTONICA 50ML EUDAMED
- Device Name
- MARISOL HYPERTONICA 50ML EUDAMED
- Model / Reference
- 40002363 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08606015660561 EUDAMED
- Basic UDI-DI
- B-08606015660561 EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS 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
Marisol Hypertonica 50ml 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-08606015660561 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 61f6b413-a3d6-4cae-879f-d3ea2155a203 61 fields · synced Jun 19, 2026