Identity
- Device Name
- Automatic Nucleic Acid Extractor EUDAMED
- Model / Reference
- ArchiPure 96 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974795551068 EUDAMED
- Basic UDI-DI
- 6974795551006GY EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES 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
Automatic Nucleic Acid Extractor by RocGene (Xuzhou) Technology Limited — 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 | 6974795551006GY | Class A | Active |
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Manufacturer
- Manufacturer
- RocGene (Xuzhou) Technology Limited
- EUDAMED SRN
- CN-MF-000024511
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f0f64000-f50f-44d8-b4c3-4b25e01bb7e7 61 fields · synced Jul 9, 2026