Identity
- Trade Name
- POLITER EUDAMED
- Device Name
- Politer EUDAMED
- Model / Reference
- With or without needle(s) EUDAMEDR42502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698147916524 EUDAMED
- Basic UDI-DI
- 8698147S010R0U7 EUDAMED
- EMDN Code
- H010201020201,H010201020202 EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Politer by Doğsan Tibbi̇ Malzeme Sanayi̇ A.ş. — Class III — 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 | 8698147S010R0U7 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Doğsan Tibbi̇ Malzeme Sanayi̇ A.ş.
- EUDAMED SRN
- TR-MF-000016026
Sources (1)
- EUDAMED 72647d68-f601-4459-88b2-b52c6d6b3701 61 fields · synced Jun 19, 2026