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Nucleic Acid Isolation System
EUDAMEDClass A (EU MDR)
Ref 02-14-01-0014-00Model EXM3000Ref 02-14-01-0013-00Ref 02-14-02-0013-00Model EXM6000, EXM6200Ref 02-14-02-0014-00
by Zybio Inc.
Identity
- Device Name
- Nucleic Acid Isolation System EUDAMED
- Model / Reference
- EXM3000 EUDAMED02-14-01-0014-00 EUDAMED02-14-01-0013-00 EUDAMEDEXM6000, EXM6200 EUDAMED02-14-02-0013-00 EUDAMED02-14-02-0014-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262865561 EUDAMED06973262865554 EUDAMED06973262866001 EUDAMED06973262866018 EUDAMED
- Basic UDI-DI
- 69732628600004ZE EUDAMED69732628600005ZG EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Category: Nucleic acid sample preparation instrument IVD
Nucleic Acid Isolation System by Zybio Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69732628600004ZE | Class A | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 7275f09e-ddae-4cad-ac33-66b8112c448d 61 fields · synced Jul 31, 2026
- EUDAMED 4588ed5a-190f-4355-881a-1459e0ad139a 61 fields · synced May 18, 2026
- EUDAMED b10ca9a4-40b2-4110-a4e7-d31aeb4d9ecf 61 fields · synced May 18, 2026
- EUDAMED 034ebdda-15d5-4079-ab71-53562a928abc 61 fields · synced May 18, 2026