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Nucleic Acid Extraction Kit (Spin Column)
EUDAMEDClass A (EU MDR)
Ref P08201T2050
Identity
- Device Name
- Nucleic Acid Extraction Kit (Spin Column) EUDAMED
- Model / Reference
- P08201T2050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895477994 EUDAMED
- Basic UDI-DI
- 697089547NAEK01R4 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
- Romania 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 Kit (Spin Column) by Jiangsu Mole Bioscience Co., LTD. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697089547NAEK01R4 | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 26820f89-87b8-4a51-ac7a-8e0008d6ba52 61 fields · synced Jun 18, 2026