Identity
- Trade Name
- HEMOLYSIS WASHING SOLUTION 90H EUDAMED
- Device Name
- HEMOLYSIS WASHING SOLUTION 90H EUDAMED
- Model / Reference
- 107374 EUDAMED105728 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486033738 EUDAMEDD-105728MY EUDAMED
- Basic UDI-DI
- 4987486BC0107374H3 EUDAMEDB-105728MY EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Ireland EUDAMEDAustria 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
Hemolysis Washing Solution 90h by ARKRAY Factory, Inc. — 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 | 4987486BC0107374H3 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 4987486BC0107374H3 | Class A | Active |
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Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (2)
- EUDAMED e3ddc8d0-e916-475f-9140-a34a9edc3e24 61 fields · synced Jul 25, 2026
- EUDAMED 586fadd2-d627-4b00-853c-5de166c77585 61 fields · synced May 19, 2026