Identity
- Trade Name
- ENTPROMED EUDAMED
- Device Name
- Harici Burun Ateli EUDAMED
- Model / Reference
- AG 021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683400978203 EUDAMED
- Basic UDI-DI
- 86834009BA7800AU EUDAMED
- EMDN Code
- P020203 NASAL SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Category: External nasal splint
Entpromed by Entpromed Sağlik Ürünleri̇ San. Ve Ti̇c. A.ş. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as External nasal splint.
- DENVER SPLINT — Summit Medical, LLC · Class I
- External aluminium nasal splint — Spiggle & Theis Medizintechnik GmbH · Class I
- DENVER SPLINT — Summit Medical, LLC · Class I
- BRIDGEMASTER™ — MEDTRONIC XOMED, INC. · Class I
- Aquaplast PS™ — Qfix · Class I
- DENVER SPLINT — Summit Medical, LLC · Class I
- Equipment box for external nasal splints — Spiggle & Theis Medizintechnik GmbH · Class I
- DENVER SPLINT — Summit Medical, LLC · 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 | 86834009BA7800AU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Entpromed Sağlik Ürünleri̇ San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000022407
Sources (1)
- EUDAMED e19027ba-3e25-45e2-b820-f10e7c5612eb 61 fields · synced Sep 26, 2026