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qMate Mini Nucleic Acid Extraction System
EUDAMEDClass A (EU MDR)
Ref H691101Model qMate mini Dx
Identity
- Device Name
- qMate Mini Nucleic Acid Extraction System EUDAMED
- Model / Reference
- qMate mini Dx EUDAMEDH691101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974149860068 EUDAMED
- Basic UDI-DI
- 697414986027NA EUDAMED
- Direct Marketing DI
- 06974149860068 EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
qMate Mini Nucleic Acid Extraction System by Aperbio Technologies (Suzhou) Co., Ltd — 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 | 697414986027NA | Class A | Active |
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Manufacturer
- Manufacturer
- Aperbio Technologies (Suzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000045149
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 8ce0ff0f-7181-4af1-819d-b27eea221f12 61 fields · synced Jun 18, 2026