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Fast Real-time PCR System
EUDAMEDClass A (EU MDR)
Ref 02-17-01-0011-00Model EXP 160, EXP 161, EXP 162Ref 02-17-01-0009-00Ref 02-17-01-0007-00
by Zybio Inc.
Identity
- Device Name
- Fast Real-time PCR System EUDAMED
- Model / Reference
- EXP 160, EXP 161, EXP 162 EUDAMED02-17-01-0011-00 EUDAMED02-17-01-0009-00 EUDAMED02-17-01-0007-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262864397 EUDAMED06973262864380 EUDAMED06973262864373 EUDAMED
- Basic UDI-DI
- 69732628600002ZA 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
Fast 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 | 69732628600002ZA | 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 (3)
- EUDAMED aa6f3850-0341-4305-9006-2020ca8c124c 61 fields · synced Jul 17, 2026
- EUDAMED 4ae1df03-c626-4d49-9274-c23138990e08 61 fields · synced May 16, 2026
- EUDAMED 9e74cee1-e32f-4df6-bf8d-8d37b66f2fd4 61 fields · synced May 18, 2026