← Back to catalogue
Nucleic Acid Extraction Reagents(Magnetic Bead)
EUDAMEDClass A (EU MDR)
Ref MTQM064Model T-16,T-32,T-48,T-64,T-96,T-200,T-960Ref MTQM036Model TM-36Ref MTQ048Ref MTQ036Ref MTQ016
Identity
- Trade Name
- Nucleic Acid Extraction Reagents(Magnetic Bead) EUDAMED
- Device Name
- Nucleic Acid Extraction Reagents(Magnetic Bead) EUDAMEDNucleic Acid Extraction Reagents (Magnetic Bead) EUDAMED
- Model / Reference
- T-16,T-32,T-48,T-64,T-96,T-200,T-960 EUDAMEDMTQM064 EUDAMEDTM-36 EUDAMEDMTQM036 EUDAMEDMTQ048 EUDAMEDMTQ036 EUDAMEDMTQ016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974081870316 EUDAMED06974081870347 EUDAMED06974081870613 EUDAMED06974081870323 EUDAMED06974081870637 EUDAMED
- Basic UDI-DI
- 697408187MTQVT EUDAMED697408187R044JD 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
- Spain EUDAMEDFrance 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 Reagents(Magnetic Bead) by Singuway Biotech Inc. — 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 | 697408187MTQVT | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Singuway Biotech Inc.
- EUDAMED SRN
- CN-MF-000027180
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (5)
- EUDAMED 36165e4b-12c9-4946-a3d2-62b501fc7172 61 fields · synced Jul 27, 2026
- EUDAMED 8b889ee6-486f-471b-8c23-c95365413579 61 fields · synced May 17, 2026
- EUDAMED 76a361dd-4150-4927-a248-4b8eaed542be 61 fields · synced May 17, 2026
- EUDAMED 8c5d7a1c-7ec7-4a4c-80bf-b5c37353ad5a 61 fields · synced May 17, 2026
- EUDAMED 78dcad10-ea05-4898-924c-77d9ce35c6de 61 fields · synced May 19, 2026