Identity
- Trade Name
- Density Reagent EUDAMED
- Device Name
- Density Reagent EUDAMED
- Model / Reference
- CVGIDR480 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973094411103 EUDAMED
- Basic UDI-DI
- B-06973094411103 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
Density Reagent by Junocare Medical Devices Ltd — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973094411103 | 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 (1)
- EUDAMED 5e9ae43d-ae63-4378-820c-26c1885532bb 61 fields · synced Jun 18, 2026