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Pre-Cut Internal Splint
EUDAMEDClass I (EU MDR)
Ref 20-10515Model Internal Nasal Splint
Identity
- Trade Name
- Pre-Cut Internal Splint EUDAMED
- Device Name
- Internal Nasal Splint EUDAMED
- Model / Reference
- Internal Nasal Splint EUDAMED20-10515 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818501023301 EUDAMED
- Basic UDI-DI
- 081850102IntNasalSplintHX EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Pre-Cut Internal Splint by Invotec International, Inc. — Class I — 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 | 081850102IntNasalSplintHX | Class I | Active |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
- EUDAMED SRN
- US-MF-000024855
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 21321cc8-2a73-4948-8cf4-df6c49e34687 61 fields · synced Jul 10, 2026