← Back to catalogue
9799140105
EUDAMEDClass A (EU MDR)
Ref 9799140105Model Swab:DirectTM Extraction Kit, Swab:DirectTM Extraction Kit (2mL) / Trans:DirectTM Extraction Kit
Identity
- Model / Reference
- Swab:DirectTM Extraction Kit, Swab:DirectTM Extraction Kit (2mL) / Trans:DirectTM Extraction Kit EUDAMED9799140105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800118520412 EUDAMED
- Basic UDI-DI
- 88001185HR0020413H EUDAMED
- Direct Marketing DI
- 08800118520412 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
9799140105 by Genesystem Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- 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
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- 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 | 88001185HR0020413H | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genesystem Co., Ltd.
- EUDAMED SRN
- KR-MF-000022998
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED d89d0c77-fd9f-45a3-b1fb-a2add903c7f2 61 fields · synced Jun 20, 2026