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Cell Preservative Fluid
EUDAMEDClass I (EU MDR)
Ref C0113JN58-2Ref CVG500V10Ref CVG500V10
Identity
- Trade Name
- Cell Preservative Fluid EUDAMED
- Device Name
- Cell Preservative Fluid EUDAMEDCell Preservative Solution EUDAMED
- Model / Reference
- C0113JN58-2 EUDAMEDCVG500V10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973094411585 EUDAMED06973094411011 EUDAMED
- Basic UDI-DI
- B-06973094411585 EUDAMEDB-06973094411011 EUDAMED697309441vails10CB EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass A EUDAMED
- Market of Registration
- Greece EUDAMEDSpain 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
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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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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-06973094411585 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973094411585 | 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 (3)
- EUDAMED c75ff60d-98fa-4979-8092-91b71a109b0c 61 fields · synced Jul 21, 2026
- EUDAMED 47c64274-e6e1-437a-92ab-694c17af259b 61 fields · synced May 17, 2026
- EUDAMED 7b1e7b24-879b-4a60-be64-8cd5444af808 61 fields · synced Jul 13, 2026