Identity
- Trade Name
- External Nasal Splint (Large) EUDAMED
- Device Name
- External Nasal Splint (Large) EUDAMED
- Model / Reference
- NZ3243-LGE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421902825088 EUDAMED
- Basic UDI-DI
- 942190282508NZ3243_LGE9P EUDAMED
- Direct Marketing DI
- 09421902825088 EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Estonia 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
No
EUDAMED
External Nasal Splint (Large) by Adept Medical Ltd — 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 | 942190282508NZ3243_LGE9P | Class I | Active |
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Manufacturer
- Manufacturer
- Adept Medical Ltd
- EUDAMED SRN
- NZ-MF-000003374
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED f176af04-75b1-4646-ab2b-d376e1843b41 61 fields · synced Jul 9, 2026