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Quantitative Real-time PCR System
EUDAMEDClass A (EU MDR)
Ref 02-17-01-0012-00Model ZIP-96V
by Zybio Inc.
Identity
- Device Name
- Quantitative Real-time PCR System EUDAMED
- Model / Reference
- ZIP-96V EUDAMED02-17-01-0012-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973262866124 EUDAMED
- Basic UDI-DI
- 69732628600001Z8 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
Quantitative Real-time PCR System by Zybio Inc. — 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 | 69732628600001Z8 | 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 (1)
- EUDAMED 8046bbba-18c2-451a-8854-09d350a0649b 61 fields · synced Jun 19, 2026