← Back to catalogue
Nucleic Acid Extraction & Purification Kit（Magnetic beads method）
EUDAMEDClass A (EU MDR)
Ref SKYE203-8Model 32T/Kit,64T/Kit.Ref SKYE203-1
Identity
- Device Name
- Nucleic Acid Extraction & Purification Kit（Magnetic beads method） EUDAMED
- Model / Reference
- 32T/Kit,64T/Kit. EUDAMEDSKYE203-8 EUDAMEDSKYE203-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974195301621 EUDAMED06974195301638 EUDAMED
- Basic UDI-DI
- 6974195307321052SKY012877 EUDAMED
- Direct Marketing DI
- 06974195301621 EUDAMED06974195301638 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMEDW01010199 ENZYMES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMEDTürkiye 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
Nucleic Acid Extraction & Purification Kit（Magnetic beads method） by Mabsky Bio-Tech Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 6974195307321052SKY012877 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mabsky Bio-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000038680
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (2)
- EUDAMED 685f5745-b9b7-4001-a339-16e9e1ed98a3 61 fields · synced Jul 10, 2026
- EUDAMED bbb264eb-7cca-413c-b2bf-e0cd129cb2ff 61 fields · synced May 18, 2026