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Quantitative Real-time PCR System
EUDAMEDClass A (EU MDR)
Ref 02-17-01-0021-00Model EXP 960, EXP 961, EXP 962, EXP 963Ref 02-17-01-0022-00
by Zybio Inc.
Identity
- Trade Name
- Quantitative Real-time PCR System EUDAMED
- Device Name
- Quantitative Real-time PCR System EUDAMED
- Model / Reference
- EXP 960, EXP 961, EXP 962, EXP 963 EUDAMED02-17-01-0021-00 EUDAMED02-17-01-0022-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967205173 EUDAMED06941967205180 EUDAMED
- Basic UDI-DI
- 697326286000792G 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
Quantitative Real-time PCR 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 | 697326286000792G | 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 (2)
- EUDAMED df06d4d5-cc7a-4f9b-8a23-db4bb5429d82 61 fields · synced Sep 18, 2026
- EUDAMED 52f01c86-8d6a-4460-84c6-2a6d62e0bdbc 61 fields · synced May 18, 2026