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Alkaline Clean
EUDAMEDClass A (EU MDR)
Ref 1010103000Model 6×380 mL; 4×500 mL; 2×2 L
Identity
- Device Name
- Alkaline Clean EUDAMED
- Model / Reference
- 6×380 mL; 4×500 mL; 2×2 L EUDAMED1010103000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975090506463 EUDAMED
- Basic UDI-DI
- 697509050010184 EUDAMED
- Direct Marketing DI
- 06975090506463 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Alkaline Clean by Accucise Diagnostics Inc. — 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 | 697509050010184 | Class A | Active |
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Manufacturer
- Manufacturer
- Accucise Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000045017
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED b02f99d9-1e47-4818-8765-a109ab2c6d0b 61 fields · synced Jun 18, 2026