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Promotor 960 Real-Time PCR System
EUDAMEDClass A (EU MDR)
Ref P111-2011-201Model RTQ-960
Identity
- Trade Name
- Promotor 960 Real-Time PCR System EUDAMED
- Device Name
- 960 Real-Time PCR System EUDAMED
- Model / Reference
- RTQ-960 EUDAMEDP111-2011-201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921756498122 EUDAMED
- Basic UDI-DI
- 6921756499990012WU EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Promotor 960 Real-Time PCR System by Acon Biotech (Hangzhou) 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 | 6921756499990012WU | Class A | Active |
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Manufacturer
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000006977
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED c64198b5-774c-4c14-afea-c1f33ea9324a 61 fields · synced Jun 19, 2026