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Automatic Capillary Electrophoresis Instrument
EUDAMEDClass A (EU MDR)
Ref A01010010Model CE2400
Identity
- Device Name
- Automatic Capillary Electrophoresis Instrument EUDAMED
- Model / Reference
- CE2400 EUDAMEDA01010010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500552 EUDAMED
- Basic UDI-DI
- 069370445acapeW9 EUDAMED
- Direct Marketing DI
- 06937044500552 EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland 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 Capillary Electrophoresis Instrument by Ningbo HEALTH Gene Technologies 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 | 069370445acapeW9 | Class A | Active |
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Manufacturer
- Manufacturer
- Ningbo HEALTH Gene Technologies Co., LTD.
- EUDAMED SRN
- CN-MF-000002278
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 1745389a-4696-44f0-9884-81846b173603 61 fields · synced Jul 26, 2026