Identity
- Trade Name
- DS DILUENT EUDAMED
- Device Name
- DS DILUENT EUDAMED
- Model / Reference
- 5950MN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681812525091 EUDAMED
- Basic UDI-DI
- 86818125HD099KU EUDAMED
- Direct Marketing DI
- 08681812525091 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Ds Diluent by Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 86818125HD099KU | Class A | Active |
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Manufacturer
- Manufacturer
- Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000027166
Sources (1)
- EUDAMED 132b4f4e-37e8-4011-b386-f6fab19c9203 61 fields · synced Oct 6, 2026