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Real-Time PCR Cycler
EUDAMEDClass A (EU MDR)
Ref Arcus96Model AIamp Arcus96S, AIamp Arcus96L
Identity
- Device Name
- Real-Time PCR Cycler EUDAMED
- Model / Reference
- AIamp Arcus96S, AIamp Arcus96L EUDAMEDArcus96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 880988550085PM EUDAMED
- Basic UDI-DI
- 880988550085PM EUDAMED
- Direct Marketing DI
- 880988550085PM EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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 Cycler by AIGENE 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 | 880988550085PM | Class A | Active |
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Manufacturer
- Manufacturer
- AIGENE Co., Ltd.
- EUDAMED SRN
- KR-MF-000041502
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 09cfc2dc-2014-4d9d-9380-341103edd94c 61 fields · synced Jun 18, 2026