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Procleix Reagent Preparation Incubator 250
EUDAMEDClass A (EU MDR)
Ref 740820Ref 740817
Identity
- Trade Name
- Procleix Reagent Preparation Incubator 250 EUDAMEDProcleix Reagent Preparation Incubator EUDAMED
- Device Name
- Procleix Reagent Preparation Incubator 250 EUDAMEDProcleix Reagent Preparation Incubator EUDAMED
- Model / Reference
- 740820 EUDAMED740817 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00866489000067 EUDAMED00859882007702 EUDAMED
- Basic UDI-DI
- 08664890000RPI00185 EUDAMED0859882007RPI004FK EUDAMED
- Direct Marketing DI
- 00866489000067 EUDAMED00859882007702 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 Preparation Incubator 250 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 | 08664890000RPI00185 | 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 (2)
- EUDAMED c57c7d3d-4fd9-4e41-8c75-6e1be5a7d51b 61 fields · synced Jul 12, 2026
- EUDAMED 7ea54fc8-92ad-4a22-848a-b37ef8c81b89 61 fields · synced May 18, 2026