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Control Dilution Set 80
EUDAMEDClass IVD General (EU MDR)
Ref 42512Ref 71265Ref 71277
Identity
- Trade Name
- CONTROL DILUTION SET 80 EUDAMED
- Device Name
- CONTROL DILUTION SET 80 EUDAMED
- Model / Reference
- 42512 EUDAMED71265 EUDAMED71277 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-42512G8 EUDAMEDD-71265H8 EUDAMEDD-71277HF EUDAMED
- Basic UDI-DI
- B-42512G8 EUDAMEDB-71265H8 EUDAMEDB-71277HF 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
Control Dilution Set 80 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-42512G8 | 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 b2cf4bae-1fc9-4586-a0f2-416af7f63550 61 fields · synced Jul 29, 2026
- EUDAMED c628b3b4-c6ad-4416-b6d6-5b827f0ab334 61 fields · synced May 17, 2026
- EUDAMED 241baedb-26e9-4bbc-b31e-d122c27c3253 61 fields · synced May 18, 2026