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PoET Instrument
EUDAMEDClass A (EU MDR)
Ref P9A
by Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Identity
- Trade Name
- PoET Instrument EUDAMED
- Device Name
- PoET Instrument EUDAMED
- Model / Reference
- P9A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262353370162 EUDAMED
- Basic UDI-DI
- 42623533727MF EUDAMED
- Direct Marketing DI
- 04262353370162 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
Category: Nucleic acid sample preparation instrument IVD
PoET Instrument by Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH — Class A — IVDR — listed in EUDAMED
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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 | 42623533727MF | Class A | Active |
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Manufacturer
- Manufacturer
- Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
- EUDAMED SRN
- DE-MF-000025295
Sources (1)
- EUDAMED 9a5942ee-74ee-4690-a76f-8725605b6d96 61 fields · synced Jul 24, 2026