Identity
- Trade Name
- Procleix Reagent Equilibration System EUDAMED
- Device Name
- Procleix Reagent Equilibration System EUDAMED
- Model / Reference
- 741597 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00859882007771 EUDAMED
- Basic UDI-DI
- 0859882007RES001DS EUDAMED
- Direct Marketing DI
- 00859882007771 EUDAMED
- EMDN Code
- W02079099 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Procleix Reagent Equilibration System by Grifols Diagnostic Solutions 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 | 0859882007RES001DS | Class A | Active |
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Manufacturer
- Manufacturer
- Grifols Diagnostic Solutions Inc.
- EUDAMED SRN
- US-MF-000004304
- Authorised Representative
- Diagnostic Grifols, S.A. ES-AR-000001573
Sources (1)
- EUDAMED 84f2ca1d-997d-46aa-acf5-5f93bd70462b 61 fields · synced Jul 14, 2026