Identity
- Trade Name
- SA-10 EUDAMED
- Device Name
- Hydrogen Peroxide Sterilizing Agents for Use in Hydrogen Peorxide Sterilizers for Invasive and Non Invasive Medical Devcies EUDAMED
- Model / Reference
- SA-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809416740867 EUDAMED
- Basic UDI-DI
- 880941674SA2L EUDAMED
- EMDN Code
- S900101 HYDROGEN PEROXIDE CARTRIDGES EUDAMED
Classification
- Device Class
- Class IIb 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
Sa-10 by LowTem Co., Ltd. — Class IIb — 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 | 880941674SA2L | Class IIb | 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 0db83c97-5b8b-4767-936b-67a71abc3e04 61 fields · synced Jun 18, 2026