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Nucleic Acid Extraction or Purification Kit
EUDAMEDClass A (EU MDR)
Ref XB03076Ref 1060065Ref XB16028
Identity
- Device Name
- Nucleic Acid Extraction or Purification Kit EUDAMED
- Model / Reference
- XB03076 EUDAMED1060065 EUDAMEDXB16028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500347 EUDAMED06937044500309 EUDAMED06937044500385 EUDAMED
- Basic UDI-DI
- 069370445nacie1060167YT EUDAMED069370445nacie1060059YP EUDAMED069370445nacieXB09034TA EUDAMED
- Direct Marketing DI
- 06937044500347 EUDAMED06937044500309 EUDAMED06937044500385 EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Nucleic Acid Extraction or Purification Kit by Ningbo HEALTH Gene Technologies 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 | 069370445nacie1060167YT | Class A | Active |
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Manufacturer
- Manufacturer
- Ningbo HEALTH Gene Technologies Co., LTD.
- EUDAMED SRN
- CN-MF-000002278
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED b28a64e1-c722-487a-a26f-83585b26f9b6 61 fields · synced Jul 25, 2026
- EUDAMED d1164a63-be23-418a-a1db-38fc0a51b7a5 61 fields · synced May 18, 2026
- EUDAMED 82813fb9-ee82-4448-9831-1e0458daed23 61 fields · synced May 18, 2026