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Gyn Cytology Test Kit
EUDAMEDClass I (EU MDR)
Ref 90-1350-50Ref C0181JN18Ref 90-1350-50
Identity
- Trade Name
- Gyn Cytology Test Kit EUDAMED
- Device Name
- Gyn Cytology Test Kit EUDAMED
- Model / Reference
- 90-1350-50 EUDAMEDC0181JN18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973094411233 EUDAMED06973094411417 EUDAMED
- Basic UDI-DI
- B-06973094411233 EUDAMEDB-06973094411417 EUDAMED697309441TestKit6T EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMEDW0103010301,W0580 EUDAMEDW01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass A EUDAMED
- Market of Registration
- Germany EUDAMEDGreece 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
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-06973094411233 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06973094411233 | 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 (4)
- EUDAMED f4c79f6c-7ad6-49a6-9c33-274a0c309a51 61 fields · synced Jul 30, 2026
- EUDAMED bf1f7717-0a8c-4f26-9d0a-694333790ae3 61 fields · synced May 18, 2026
- EUDAMED 9e483f0c-897c-42e8-abad-d334fbfdce2f 61 fields · synced Jun 19, 2026
- EUDAMED 9a02c1ee-c402-4601-9a99-f65d8bd7de0d 61 fields · synced Jul 30, 2026