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Återfuktande Nässpray Apofri
EUDAMEDClass IIa (EU MDR)
Ref 55.0396Model Moistening solution for nasal use (sodium hyaluronate and dexpanthenol)
Identity
- Trade Name
- Återfuktande Nässpray Apofri EUDAMED
- Device Name
- Moistening solution for nasal use based on sodium hyaluronate and dexpanthenol EUDAMED
- Model / Reference
- Moistening solution for nasal use (sodium hyaluronate and dexpanthenol) EUDAMED55.0396 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04031626002051 EUDAMED
- Basic UDI-DI
- 4031626101365NL EUDAMED
- EMDN Code
- Q030103 NASAL IRRIGATION SOLUTIONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Återfuktande Nässpray Apofri 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 | 4031626101365NL | Class IIa | Active |
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Manufacturer
- Manufacturer
- URSAPHARM Arzneimittel GmbH
- EUDAMED SRN
- DE-MF-000007748
Sources (1)
- EUDAMED a22c70fb-1d78-4cb7-8a4a-7a145cf6e094 61 fields · synced Jul 23, 2026