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Non Sterile-Silicone Nasal Splints
EUDAMEDClass IIa (EU MDR)
Ref 120-1020-2257Ref 120-1020-3260Ref 120-1120-3260Ref 120-1020-3257
Identity
- Device Name
- Non Sterile-Silicone Nasal Splints EUDAMEDSilicone Nasal Splints EUDAMED
- Model / Reference
- 120-1020-2257 EUDAMED120-1020-3260 EUDAMED120-1120-3260 EUDAMED120-1020-3257 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060465560308 EUDAMED05060465560421 EUDAMED05060465560414 EUDAMED05060465560391 EUDAMED
- Basic UDI-DI
- 506046556120-10AK EUDAMED506046556120-11AM EUDAMED
- Unit of Use DI
- 05060465560407 EUDAMED
- EMDN Code
- P020203 NASAL SPLINTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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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- Equipment box for external nasal splints — Spiggle & Theis Medizintechnik GmbH · Class I
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 (4)
- EUDAMED fb36524e-47e8-4ecd-85e7-405da4670cf1 61 fields · synced Jul 20, 2026
- EUDAMED 45adaf5e-d9fe-451a-b4c9-6f781ccfe24f 61 fields · synced May 17, 2026
- EUDAMED 3fcaa604-5ebb-4a78-85d0-55a4c55239e5 61 fields · synced May 18, 2026
- EUDAMED a23aa618-1fce-4853-ba0d-d0ae1b4cd164 61 fields · synced May 18, 2026