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AccuDiag™ Folate ELISA
EUDAMEDClass IVD General (EU MDR)
Ref 3127-15Model Anemia ELISA Kit
Identity
- Trade Name
- AccuDiag™ Folate ELISA EUDAMED
- Device Name
- AccuDiag™ Folate ELISA EUDAMED
- Model / Reference
- Anemia ELISA Kit EUDAMED3127-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850049545006 EUDAMED
- Basic UDI-DI
- B-00850049545006 EUDAMED
- EMDN Code
- W0102070103 FOLATE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
AccuDiag™ Folate ELISA by Diagnostic Automation/ Cortez Diagnostics, 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-00850049545006 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagnostic Automation/ Cortez Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000051963
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 480a2221-82ab-46ce-9920-ee5e18fab7b0 61 fields · synced Jul 31, 2026