Identity
- Trade Name
- 15 ML REAGENT CUP EUDAMED
- Device Name
- 10 ML REAGENT CUP EUDAMED
- Model / Reference
- B1034626 EUDAMEDB1037307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03610230009406 EUDAMED
- Basic UDI-DI
- 361023reagent_cupCK EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
15 Ml Reagent Cup by Horiba Abx Sas — 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 | 361023reagent_cupCK | Class A | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (1)
- EUDAMED 35a9fab5-1515-4621-a40d-c601f2064a75 61 fields · synced Jul 28, 2026