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hysan Hypertonic Nasal Spray
EUDAMEDClass IIa (EU MDR)
Ref 55.1821Model Salt solution for nasal use
Identity
- Trade Name
- hysan Hypertonic Nasal Spray EUDAMED
- Device Name
- Hypertonic salt solution for nasal use EUDAMED
- Model / Reference
- Salt solution for nasal use EUDAMED55.1821 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04031626001542 EUDAMED
- Basic UDI-DI
- 4031626103064NH EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
Yes
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
hysan Hypertonic Nasal Spray by URSAPHARM Arzneimittel GmbH — 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 | 4031626103064NH | Class IIa | Active |
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Manufacturer
- Manufacturer
- URSAPHARM Arzneimittel GmbH
- EUDAMED SRN
- DE-MF-000007748
Sources (1)
- EUDAMED 0866c15c-4dcc-4157-8e5a-1aacd867cbc8 61 fields · synced Jul 30, 2026