Identity
- Trade Name
- Gyn Cytology Test Kit EUDAMED
- Device Name
- Gyn Cytology Test Kit EUDAMED
- Model / Reference
- CVG480GYN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973094411097 EUDAMED
- Basic UDI-DI
- B-06973094411097 EUDAMED697309441TestKit6T EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMEDW01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass A 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
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
Gyn Cytology Test Kit by Junocare Medical Devices Ltd — Class I — IVDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06973094411097 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973094411097 | 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 7f01dc1a-b96b-407e-bc68-469fd9aa4900 61 fields · synced Jun 18, 2026
- EUDAMED 8e170da3-a11f-418a-8c63-8733b2b5776b 61 fields · synced Jun 18, 2026