Identity
- Trade Name
- Red Cell Preservative Fluid EUDAMED
- Device Name
- Red Cell Preservative Fluid EUDAMED
- Model / Reference
- C0131JN38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973094411424 EUDAMED
- Basic UDI-DI
- B-06973094411424 EUDAMED697309441RedFluiUC EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass A EUDAMED
- Market of Registration
- Greece EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Red Cell Preservative Fluid by Junocare Medical Devices Ltd — Class I — IVDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06973094411424 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973094411424 | Class I | Active |
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Manufacturer
- Manufacturer
- Junocare Medical Devices Ltd
- EUDAMED SRN
- CN-MF-000030653
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (2)
- EUDAMED 1372c8d9-ba7f-4a76-b582-073f7fa1ec65 61 fields · synced Jun 19, 2026
- EUDAMED 86675627-94c7-466a-abeb-8bb1b988e860 61 fields · synced Jun 19, 2026