Identity
- Trade Name
- ProciseDx Calibration Cartridge EUDAMED
- Device Name
- ProciseDx Calibration Cartridge EUDAMED
- Model / Reference
- 4759 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08100322947594 EUDAMED
- Basic UDI-DI
- 081003229PDXB475922V8 EUDAMED
- Direct Marketing DI
- 08100322947594 EUDAMED
- EMDN Code
- W0201069080 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - HARDWARE 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ProciseDx Calibration Cartridge by ProciseDx Inc. — 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 | 081003229PDXB475922V8 | Class A | Active |
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Manufacturer
- Manufacturer
- ProciseDx Inc.
- EUDAMED SRN
- US-MF-000040747
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 4f394f85-6994-40f3-8ef9-65512fc0eee7 61 fields · synced Aug 1, 2026