Solatronic SLE
by Elektronika i Elektromedycyna M.Lewandowski Sp.J. Poland EUDAMED
Ref Solatronic SLE
EMDN Z120601,Z120610,Z120615
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberTNP/MDR/0030/2034/2025 | Date23 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- TNP/MDR/0030/2034/2025 Supplemented
Quality management system EU MDR
- Notified body
- TUV NORD Polska Sp. z o.o 2274
- Issued
- 23 Sep 2026
- Expires
- 16 Jan 2030
- Reason
- Other
Specification
- Model / Reference
- Solatronic SLE
- Primary DI / UDI-DI
- 05906660092025
- Basic UDI-DI
- 5906660092SLEDU
- Direct Marketing DI
- 05906660092025
- EMDN Code
- Z120601,Z120610,Z120615
- Device Class
- Class IIa
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000032400
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Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED ab86ba43-cc77-41f9-af14-92185a332d2c