Identity
- Device Name
- Non Sterile-Silicone Nasal Splints EUDAMED
- Model / Reference
- 120-1020-2060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060465560339 EUDAMED
- Basic UDI-DI
- 506046556120-10AK EUDAMED
- EMDN Code
- P020203 NASAL SPLINTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- 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
Yes
EUDAMED
Category: External nasal splint
Non Sterile-Silicone Nasal Splints by Medasil Surgical Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as External nasal splint.
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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 | 506046556120-10AK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medasil Surgical Limited
- EUDAMED SRN
- GB-MF-000009549
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED f5583683-c71f-43d2-8bae-887fc1d26db1 61 fields · synced Jun 19, 2026