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Thermal Cycler
EUDAMEDClass A (EU MDR)
Ref M1601FModel WHYA10, WHYA20, WHYA30, Q200A, Q200B, Q200C, G100, WG100, G101, G200, M1601, M1601F, A08, A09
Identity
- Trade Name
- Thermal Cycler EUDAMED
- Device Name
- Thermal Cycler EUDAMED
- Model / Reference
- WHYA10, WHYA20, WHYA30, Q200A, Q200B, Q200C, G100, WG100, G101, G200, M1601, M1601F, A08, A09 EUDAMEDM1601F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226450602 EUDAMED
- Basic UDI-DI
- 697722645BTTC01QD EUDAMED
- EMDN Code
- W02039006 DNA THERMAL CYCLERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Thermal Cycler by Nanjing Poweam Medical Co., Ltd — Class A — CE/MDR — 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 | 697722645BTTC01QD | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Poweam Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000040207
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b3c5dcc1-f8b9-4b43-ac57-5c0b40f1f70a 61 fields · synced Oct 6, 2026