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EASYPREP Preservative solution
EUDAMEDClass A (EU MDR)
Ref NGY 01Model EASYPREP Preservative solution(GYN), EASYPREP Preservative solution(NON-GYN)
Identity
- Trade Name
- EASYPREP Preservative solution EUDAMED
- Device Name
- EASYPREP Preservative solution EUDAMED
- Model / Reference
- EASYPREP Preservative solution(GYN), EASYPREP Preservative solution(NON-GYN) EUDAMEDNGY 01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806125621203 EUDAMED
- Basic UDI-DI
- 88061256EZ01Q9 EUDAMED
- EMDN Code
- W01030705 FIXING REAGENTS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
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
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
EASYPREP Preservative solution by YD Diagnostics CORP. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88061256EZ01Q9 | Class A | Active |
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Manufacturer
- Manufacturer
- YD Diagnostics CORP.
- EUDAMED SRN
- KR-MF-000023981
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 26d17fad-1be6-43c5-bae1-ac5e6ad3aaef 61 fields · synced Jun 18, 2026