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Automated Nucleic Acid Detection Reaction Construction System
EUDAMEDClass A (EU MDR)
Ref 1000042Model AP10
Identity
- Trade Name
- Automated Nucleic Acid Detection Reaction Construction System EUDAMED
- Device Name
- Automated Nucleic Acid Detection Reaction Construction System EUDAMED
- Model / Reference
- AP10 EUDAMED1000042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975578360020 EUDAMED
- Basic UDI-DI
- 697557836020020001YH EUDAMED
- Direct Marketing DI
- 06975578360020 EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automated Nucleic Acid Detection Reaction Construction System by Pilot Gene Technology (Hangzhou) Co., Ltd — Class A — IVDR — listed in EUDAMED
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 | 697557836020020001YH | Class A | Active |
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Manufacturer
- Manufacturer
- Pilot Gene Technology (Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000023002
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 75343b9b-bd31-48bc-8dc7-cb99c26fbf25 61 fields · synced Jul 14, 2026