Identity
- Device Name
- Aegaeon Digital PCR System EUDAMED
- Model / Reference
- XW Dx EUDAMEDH631104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974149860020 EUDAMED
- Basic UDI-DI
- 697414986XW3XH EUDAMED
- Direct Marketing DI
- 06974149860020 EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Aegaeon Digital PCR System by Aperbio Technologies (Suzhou) 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 | 697414986XW3XH | Class A | Active |
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Manufacturer
- Manufacturer
- Aperbio Technologies (Suzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000045149
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 2d9a8a6d-0e29-4798-b8b2-df044b218118 61 fields · synced Jul 28, 2026