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System Wash Solution [en]
EUDAMEDClass A (EU MDR)
Ref 8020MNModel Please see UDI-DIs for details.
Identity
- Trade Name
- SYSTEM WASH SOLUTION [EN] EUDAMED
- Device Name
- Auxiliary Reagent EUDAMED
- Model / Reference
- Please see UDI-DIs for details. EUDAMED8020MN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 86818125008906 EUDAMED
- Basic UDI-DI
- 869901528AR00LM EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) 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
Yes
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
System Wash Solution [en] 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 | 869901528AR00LM | Class A | Active |
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Manufacturer
- Manufacturer
- Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000027166
Sources (1)
- EUDAMED 4ff09215-e7e7-44e0-b1cd-1f2f87e1a8ba 61 fields · synced Oct 6, 2026