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Low Temperature Sterilizer
EUDAMEDClass IIa (EU MDR)
Ref PL0415S1 Model PL1, PL2, PL3, PL4
Identity
- Trade Name
- Low Temperature Sterilizer EUDAMED
- Device Name
- Low Temperature Sterilizer EUDAMED
- Model / Reference
- PL1, PL2, PL3, PL4 EUDAMEDPL0415S1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681020039670 EUDAMED
- Basic UDI-DI
- 8681020039SMPL7G EUDAMED
- Direct Marketing DI
- 08681020039670 EUDAMED
- EMDN Code
- S900199 DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Low Temperature Sterilizer by Steri̇lmed Medi̇cal Elektri̇k Elektroni̇k Otomasyon İnşaat Gida Sanayi̇ Ve Diş Ti̇caret Li̇mi̇ted Şi̇rketi̇ — Class IIa…
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 | 8681020039SMPL7G | Class IIa | Active |
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Manufacturer
- Manufacturer
- Steri̇lmed Medi̇cal Elektri̇k Elektroni̇k Otomasyon İnşaat Gida Sanayi̇ Ve Diş Ti̇caret Li̇mi̇ted Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000018720
Sources (1)
- EUDAMED 0cb3e271-8549-463a-bcc3-33f505a5f50b 61 fields · synced Oct 7, 2026