← Back to catalogue
Nucleic Acid Extraction Reagent (Swab)
EUDAMEDClass A (EU MDR)
Ref 529004Model 64T/KitRef 529006Model 32T/KitRef 529005Model 96T/Kit
Identity
- Device Name
- Nucleic Acid Extraction Reagent (Swab) EUDAMED
- Model / Reference
- 64T/Kit EUDAMED529004 EUDAMED32T/Kit EUDAMED529006 EUDAMED96T/Kit EUDAMED529005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341688189 EUDAMED06970341688165 EUDAMED06970341688196 EUDAMED
- Basic UDI-DI
- 69703416803208006JU EUDAMED69703416803208004JQ EUDAMED69703416803208007JW EUDAMED
- Direct Marketing DI
- 06970341688189 EUDAMED06970341688165 EUDAMED06970341688196 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
- Netherlands 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
Nucleic Acid Extraction Reagent (Swab) by Shenzhen Lifotronic Technology 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 | 69703416803208006JU | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED 1006c474-5575-4e74-bee3-bfffe07f25dd 61 fields · synced Aug 4, 2026
- EUDAMED 665ca108-c914-4781-bfcc-5ac9bec62ce5 61 fields · synced May 18, 2026
- EUDAMED 671eb21e-78b9-436f-9428-4518fa8f1244 61 fields · synced May 19, 2026