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Automated Nucleic Acid Purification and Real Time PCR System
EUDAMEDClass A (EU MDR)
Ref DxLab-32A
Identity
- Device Name
- Automated Nucleic Acid Purification and Real Time PCR System EUDAMED
- Model / Reference
- DxLab-32A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972221450961 EUDAMED
- Basic UDI-DI
- 697222145096G5 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Automated Nucleic Acid Purification and Real Time PCR System by CapitalBio Technology (Chengdu) Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697222145096G5 | Class A | Active |
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Manufacturer
- Manufacturer
- CapitalBio Technology (Chengdu) Co., Ltd.
- EUDAMED SRN
- CN-MF-000027694
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ec0d4cd3-6e0b-4796-a820-c982d38c66d4 61 fields · synced Jul 8, 2026