Identity
- Trade Name
- LOWTEM Smart 10 EUDAMED
- Device Name
- Low temperature hydrogen peroxide sterilizers for invasive and non invasive medical device EUDAMED
- Model / Reference
- LOWTEM Smart 10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809416740843 EUDAMED
- Basic UDI-DI
- 880941674C120DW EUDAMED
- EMDN Code
- S900199 DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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
LOWTEM Smart 10 by LowTem Co., Ltd. — Class IIa — 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 | 880941674C120DW | Class IIa | Active |
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Manufacturer
- Manufacturer
- LowTem Co., Ltd.
- EUDAMED SRN
- KR-MF-000016177
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (1)
- EUDAMED 6f2cba61-62d9-43d2-97f2-6a9588113b94 61 fields · synced Oct 6, 2026