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Plasti-Med
EUDAMEDClass IIa (EU MDR)
Ref 542039
by Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.
Identity
- Trade Name
- PLASTI-MED EUDAMED
- Device Name
- AMPLATZ RENAL DILATOR AND SHEATH SET 6-30 FR 35 cm EUDAMED
- Model / Reference
- 542039 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699412402414 EUDAMED
- Basic UDI-DI
- B-08699412402414 EUDAMED
- EMDN Code
- L06050101 NON-ENDOSCOPIC URETHRAL EXPANSION INSTRUMENTS, REUSABLE 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
Plasti-Med by Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08699412402414 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000032251
Sources (1)
- EUDAMED a95a8c35-8c64-4969-8986-6f313aaa8520 61 fields · synced Oct 7, 2026