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Real-Time PCR System
EUDAMEDClass A (EU MDR)
Ref Archimed X4Ref Archimed X6Ref Archimed 384
Identity
- Device Name
- Real-Time PCR System EUDAMED
- Model / Reference
- Archimed X4 EUDAMEDArchimed X6 EUDAMEDArchimed 384 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795551013 EUDAMED06974795551020 EUDAMED06974795551044 EUDAMED
- Basic UDI-DI
- 6974795551001CA9 EUDAMED6974795551002CAC EUDAMED6974795551004GU EUDAMED
- Direct Marketing DI
- 06974795551013 EUDAMED06974795551020 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMEDW0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Real-Time PCR System by RocGene (Xuzhou) Technology Limited — 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 | 6974795551001CA9 | Class A | Active |
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Manufacturer
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- EUDAMED SRN
- CN-MF-000024511
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 9095aee5-c3c4-4ee3-9279-7e7e9a5a0ffe 61 fields · synced Jul 30, 2026
- EUDAMED 9a989fa4-d89c-4477-ac08-1a55eedd2fe5 61 fields · synced May 17, 2026
- EUDAMED bac8732e-ce99-4b83-8ec6-a497dff3db24 61 fields · synced May 19, 2026