Identity
- Trade Name
- GENEDIAN EUDAMED
- Device Name
- Real-Time PCR System MC1000 EUDAMED
- Model / Reference
- MC-1000 EUDAMEDP112-00096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934244500122 EUDAMED
- Basic UDI-DI
- 69342445IA001FH EUDAMED
- EMDN Code
- W02050201 MICRO-ARRAY ANALYSERS EUDAMED
Classification
- Device Class
- Class A 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
Genedian by Hangzhou DIAN Biotechnology 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 | 69342445IA001FH | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou DIAN Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000007252
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b736e5fa-243f-4004-9d9b-97d3e57f8313 61 fields · synced Oct 6, 2026