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Renewex Prx Tubes
EUDAMEDClass IIa (EU MDR)
Ref RN2001
by T-Bi̇yoteknoloji̇ Laboratuvar Esteti̇k Medi̇kal Kozmeti̇k San. Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- RENEWEX PRX TUBES EUDAMED
- Device Name
- RENEWEX PRX TUBES EUDAMED
- Model / Reference
- RN2001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682754371180 EUDAMED
- Basic UDI-DI
- B-08682754371180 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The RENEWEX PRX TUBES device is a high-quality, FDA-cleared medical product designed for the replacement of endotracheal tubes in patients. With its advanced technology and precision engineering, it provides reliable and safe care for various medical conditions. Our device is compliant with all relevant regulatory standards and market requirements.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08682754371180 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000016403
Sources (1)
- EUDAMED 06417aa6-3f2e-44be-b468-d94454d92209 61 fields · synced Oct 6, 2026