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Loopamp(TM) PURE DNA Extraction Kit
EUDAMEDClass A (EU MDR)
Ref 970000Model Loopamp(TM) PURE DNA Extraction Kit
Identity
- Trade Name
- Loopamp(TM) PURE DNA Extraction Kit EUDAMED
- Model / Reference
- Loopamp(TM) PURE DNA Extraction Kit EUDAMED970000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04033145191391 EUDAMED
- Basic UDI-DI
- 4987026TD-LFPR25 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
No
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
Loopamp(TM) PURE DNA Extraction Kit by Eiken Chemical Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 4987026TD-LFPR25 | Class A | Active |
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Manufacturer
- Manufacturer
- Eiken Chemical Co., Ltd.
- EUDAMED SRN
- JP-MF-000018097
- Authorised Representative
- Human Gesellschaft für Biochemica und Diagnostica mbH DE-AR-000025586
Sources (1)
- EUDAMED 875eef3d-4aa0-4e2f-a0d2-950a9775b618 61 fields · synced Jun 18, 2026