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PoET Extraction
EUDAMEDClass A (EU MDR)
Ref P1A-24-04
by Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Identity
- Trade Name
- PoET Extraction EUDAMED
- Device Name
- PoET Extraction EUDAMED
- Model / Reference
- P1A-24-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262353370001 EUDAMED
- Basic UDI-DI
- 42623533711LY EUDAMED
- Direct Marketing DI
- 04262353370001 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS 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
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
PoET Extraction by Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH — Class A — IVDR — listed in EUDAMED
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 42623533711LY | 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 9a7f7dff-7429-4dfb-8f37-36d653907322 61 fields · synced Aug 4, 2026