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Automated Nucleic Acid Isolation System
EUDAMEDClass A (EU MDR)
Ref NE-12-T-24Model NE-02-K-12；NE-02-K-12M；NE-02-K-96；NE-02-H-96；NE-02-F-96；NE-12-T-24
Identity
- Device Name
- Automated Nucleic Acid Isolation System EUDAMED
- Model / Reference
- NE-02-K-12；NE-02-K-12M；NE-02-K-96；NE-02-H-96；NE-02-F-96；NE-12-T-24 EUDAMEDNE-12-T-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975938851052 EUDAMED
- Basic UDI-DI
- 697593885ANAISV9 EUDAMED
- Direct Marketing DI
- 06975938851052 EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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 Isolation System by Guangzhou Baybio Bio-Tech 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 | 697593885ANAISV9 | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Baybio Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000030650
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 15ec3117-0487-4fdc-9a01-40ea99ae9e92 61 fields · synced Jul 11, 2026