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Automatic nucleic acid extractor
EUDAMEDClass A (EU MDR)
Ref 06978022400013Model Pure 32
Identity
- Device Name
- Automatic nucleic acid extractor EUDAMED
- Model / Reference
- Pure 32 EUDAMED06978022400013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978022400013 EUDAMED
- Basic UDI-DI
- 69780224000137D EUDAMED
- EMDN Code
- W02050392 NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - IVD MEDICAL DEVICE SOFTWARE 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic nucleic acid extractor by Contin Instrument (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 | 69780224000137D | Class A | Active |
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Manufacturer
- Manufacturer
- Contin Instrument (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000045197
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED ef041131-e747-4582-832b-8ce05551c70a 61 fields · synced Jun 18, 2026