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Hemolysis Washing Solution 80h
EUDAMEDClass IVD General (EU MDR)
Ref 71276Ref 71264Ref 42511
Identity
- Trade Name
- HEMOLYSIS WASHING SOLUTION 80H EUDAMED
- Device Name
- HEMOLYSIS WASHING SOLUTION 80H EUDAMED
- Model / Reference
- 71276 EUDAMED71264 EUDAMED42511 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-71276HD EUDAMEDD-71264H6 EUDAMEDD-42511G6 EUDAMED
- Basic UDI-DI
- B-71276HD EUDAMEDB-71264H6 EUDAMEDB-42511G6 EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMEDFrance 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
Hemolysis Washing Solution 80h by ARKRAY Factory, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-71276HD | Class IVD General | 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 (3)
- EUDAMED 27e4263b-915e-43a3-848b-a7575bf8ed19 61 fields · synced Jul 27, 2026
- EUDAMED 1e7adfeb-20f7-4223-a846-d68e1e66f73e 61 fields · synced May 18, 2026
- EUDAMED 898008dd-c9fe-4e15-98bc-2a094dcae5ca 61 fields · synced May 18, 2026