Identity
- Trade Name
- Procleix Auto Detect Reagents EUDAMED
- Device Name
- Procleix Auto Detect Reagents EUDAMED
- Model / Reference
- 9053575 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850032683579 EUDAMED
- Basic UDI-DI
- 0859882007Procleix012ZF EUDAMED
- Direct Marketing DI
- 00850032683579 EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Procleix Auto Detect Reagents 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 | 0859882007Procleix012ZF | 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 4119b7a0-15e0-48b4-b76e-9238d759f32d 61 fields · synced Jul 11, 2026