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DNA/RNA Extraction Kit(Column)
EUDAMEDClass A (EU MDR)
Ref D202-01: 50preps/boxRef D202：96preps/boxRef D102：96preps/boxRef D801:50preps/boxRef D202:200preps/box
Identity
- Device Name
- DNA/RNA Extraction Kit(Column) EUDAMED
- Model / Reference
- D202-01: 50preps/box EUDAMEDD202：96preps/box EUDAMEDD102：96preps/box EUDAMEDD801:50preps/box EUDAMEDD202:200preps/box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974898110636 EUDAMED06974898110971 EUDAMED06974898110940 EUDAMED06974898110612 EUDAMED06974898110988 EUDAMED
- Basic UDI-DI
- 697489811000004ZA EUDAMED
- Direct Marketing DI
- 06974898110636 EUDAMED06974898110971 EUDAMED06974898110940 EUDAMED06974898110612 EUDAMED06974898110988 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
DNA/RNA Extraction Kit(Column) by Genfine Biotech(changzhou) 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 | 697489811000004ZA | Class A | Active |
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Manufacturer
- Manufacturer
- Genfine Biotech(changzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000003399
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (5)
- EUDAMED e6cd21d0-9de5-41a8-9fb4-a963fed57e55 61 fields · synced Oct 1, 2026
- EUDAMED c06b4861-9ff0-47fc-8d24-5cba34ce85f4 61 fields · synced May 17, 2026
- EUDAMED 2f19319e-6b13-4bdb-9148-3e1ca3b5712b 61 fields · synced May 18, 2026
- EUDAMED 20c5ee7b-7014-4a7b-8ebf-0c43de4cab97 61 fields · synced May 18, 2026
- EUDAMED d7512fee-89bc-4376-8af7-614bd0ece6cc 61 fields · synced May 19, 2026