Identity
- Device Name
- Real Time PCR System EUDAMED
- Model / Reference
- FS -3200 EUDAMEDFS-3200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972221450954 EUDAMED
- Basic UDI-DI
- 697222145095G3 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
Real Time PCR System by CapitalBio Technology (Chengdu) Co., Ltd. — 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 | 697222145095G3 | 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 9c35e58a-0316-47af-9755-d3f5eccc9a78 61 fields · synced Jul 29, 2026