Identity
- Trade Name
- Density Reagent EUDAMED
- Device Name
- Density Reagent EUDAMED
- Model / Reference
- C0061JK28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973094411370 EUDAMED
- Basic UDI-DI
- B-06973094411370 EUDAMED697309441DensityZJ 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
Density Reagent 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-06973094411370 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973094411370 | 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 32f0c4bd-212f-487e-b615-97276a78f8a3 61 fields · synced Jul 19, 2026
- EUDAMED 6352f8d2-843c-4a9d-a7d1-8d003c80d5ab 61 fields · synced Jul 19, 2026