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Concentrated Wash Solution
EUDAMEDClass A (EU MDR)
Ref 9905YModel Concentrated Wash SolutionRef QX9905YModel 100 mL
Identity
- Trade Name
- Concentrated Wash Solution EUDAMED
- Device Name
- Concentrated Wash Solution EUDAMED
- Model / Reference
- Concentrated Wash Solution EUDAMED9905Y EUDAMED100 mL EUDAMEDQX9905Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595748390 EUDAMED
- Basic UDI-DI
- 693659579905QW EUDAMEDB-06936595748390 EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- France EUDAMEDItaly 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Concentrated Wash Solution by Medicalsystem Biotechnology Co., Ltd. — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 693659579905QW | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 693659579905QW | Class A | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED e4bf2d19-4374-4fa7-bd49-b1fd44735f42 61 fields · synced Aug 3, 2026
- EUDAMED 83fef553-ef6c-4ca9-b90e-792cac27d74a 61 fields · synced May 17, 2026