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DNA/RNA Extraction Kit(Magnetic Beads)
EUDAMEDClass A (EU MDR)
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Identity
- Device Name
- DNA/RNA Extraction Kit(Magnetic Beads) EUDAMED
- Model / Reference
- 103-Y: 32preps/box EUDAMED204-Y: 96preps/box EUDAMED403-Y: 96preps/box EUDAMED103-B: 960preps/box EUDAMED202-B: 96preps/box EUDAMED107-B: 50preps/box EUDAMED107-Y: 12preps/box EUDAMED107-B: 960preps/box EUDAMED107-B: 25preps/box EUDAMED101-B: 960preps/box EUDAMED204-Y: 16preps/box EUDAMED107-Y: 96preps/box EUDAMED701-Y: 32preps/box EUDAMED403-B: 960preps/box EUDAMED103-B: 96preps/box EUDAMED107-Y: 48preps/box EUDAMED403-B: 50preps/box EUDAMED204-Y: 480preps/box EUDAMED701-B: 96preps/box EUDAMED101-Y: 32preps/box EUDAMED101-B: 25preps/box EUDAMED204-Y: 40preps/box EUDAMED101-B: 50preps/box EUDAMED204-Y: 960preps/box EUDAMED701-Y: 120preps/box EUDAMED103-Y: 40preps/box EUDAMED702-Y: 16preps/box EUDAMED701-Y: 24preps/box EUDAMED403-Y: 64preps/box EUDAMED702-Y: 40preps/box EUDAMED702-B: 96preps/box EUDAMED103-Y: 96preps/box EUDAMED403-B: 96preps/box EUDAMED701-Y: 12preps/box EUDAMED701-B: 960preps/box EUDAMED701-Y: 64preps/box EUDAMED103-Y: 10preps/box EUDAMED204-Y: 64preps/box EUDAMED101-Y: 96preps/box EUDAMED202-Y: 10preps/box EUDAMED202-Y: 32preps/box EUDAMED702-Y: 96preps/box EUDAMED403-Y: 32preps/box EUDAMED403-Y: 960preps/box EUDAMED403-Y: 10preps/box EUDAMED202-Y: 40preps/box EUDAMED204-Y: 32preps/box EUDAMED403-Y: 16preps/box EUDAMED202-Y: 16preps/box EUDAMED701-Y: 96preps/box EUDAMED202-Y: 64preps/box EUDAMED
Identifiers
- Primary DI / UDI-DI
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- Basic UDI-DI
- 697489811000001Z4 EUDAMED
- Direct Marketing DI
- 06974898110124 EUDAMED06974898110414 EUDAMED06974898110520 EUDAMED06974898110186 EUDAMED06974898110346 EUDAMED06974898110247 EUDAMED06974898110193 EUDAMED06974898110261 EUDAMED06974898110230 EUDAMED06974898110094 EUDAMED06974898110377 EUDAMED06974898110223 EUDAMED06974898110605 EUDAMED06974898110575 EUDAMED06974898110179 EUDAMED06974898110216 EUDAMED06974898110551 EUDAMED06974898110421 EUDAMED06974898110698 EUDAMED06974898110025 EUDAMED06974898110063 EUDAMED06974898110391 EUDAMED06974898110070 EUDAMED06974898110438 EUDAMED06974898110667 EUDAMED06974898110131 EUDAMED06974898110728 EUDAMED06974898110599 EUDAMED06974898110513 EUDAMED06974898110742 EUDAMED06974898110780 EUDAMED06974898110155 EUDAMED06974898110568 EUDAMED06974898110582 EUDAMED06974898110704 EUDAMED06974898110643 EUDAMED06974898110100 EUDAMED06974898110407 EUDAMED06974898110056 EUDAMED06974898110278 EUDAMED06974898110292 EUDAMED06974898110766 EUDAMED06974898110490 EUDAMED06974898110544 EUDAMED06974898110476 EUDAMED06974898110308 EUDAMED06974898110384 EUDAMED06974898110483 EUDAMED06974898110285 EUDAMED06974898110650 EUDAMED06974898110315 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(Magnetic Beads) 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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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 | 697489811000001Z4 | 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 (51)
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