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Real-time PCR system
EUDAMEDClass A (EU MDR)
Ref Q8804Ref Q9604Ref Q1602-FRef Q3204Ref Q1602Ref Q3202-FRef Q8802Ref H8804Ref Q9604 ProRef Q9602 Pro
Identity
- Trade Name
- Real-time PCR system EUDAMED
- Device Name
- Real-time PCR system EUDAMED
- Model / Reference
- Q8804 EUDAMEDQ9604 EUDAMEDQ1602-F EUDAMEDQ3204 EUDAMEDQ1602 EUDAMEDQ3202-F EUDAMEDQ8802 EUDAMEDH8804 EUDAMEDQ9604 Pro EUDAMEDQ9602 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975412631061 EUDAMED16975412631016 EUDAMED16975412631160 EUDAMED16975412631191 EUDAMED16975412631153 EUDAMED16975412631122 EUDAMED16975412631085 EUDAMED16975412631115 EUDAMED16975412631047 EUDAMED16975412631054 EUDAMED
- Basic UDI-DI
- 697541263PCRSPB EUDAMED
- Direct Marketing DI
- 16975412631061 EUDAMED16975412631016 EUDAMED16975412631160 EUDAMED16975412631191 EUDAMED16975412631153 EUDAMED16975412631122 EUDAMED16975412631085 EUDAMED16975412631115 EUDAMED16975412631047 EUDAMED16975412631054 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMEDSpain 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
Category: Nucleic acid sample preparation instrument IVD
Real-time PCR system by Hangzhou Bio-gener Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697541263PCRSPB | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bio-gener Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027988
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (10)
- EUDAMED 32795537-f50b-4043-b5e3-34c8139175f5 61 fields · synced Aug 3, 2026
- EUDAMED c18e8901-6701-4d80-9a09-ab34a9534f4d 61 fields · synced May 16, 2026
- EUDAMED b405ffd2-6324-4008-8d60-f76fb75e235c 61 fields · synced May 16, 2026
- EUDAMED d2512bb6-aabc-4aef-a628-61c541cdaeda 61 fields · synced May 17, 2026
- EUDAMED 5deb078c-8664-450b-92cf-4d15c8ffd462 61 fields · synced May 17, 2026
- EUDAMED f61e79e4-4747-46f2-b563-255cb57a7750 61 fields · synced May 17, 2026
- EUDAMED b378fc6d-06ab-4e85-a609-94aa0332286c 61 fields · synced May 17, 2026
- EUDAMED e2eb5d9f-b39a-4d54-93ea-752c676e41a2 61 fields · synced May 18, 2026
- EUDAMED 1d489a7e-56c1-4129-b6fa-8f869b4b3fb5 61 fields · synced May 18, 2026
- EUDAMED 164cf6df-fb8d-4173-908b-a99b0c41bf0f 61 fields · synced May 19, 2026