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Nucleic Acid Extraction or Purification Kit
EUDAMEDClass A (EU MDR)
Ref 1060089
Identity
- Device Name
- Nucleic Acid Extraction or Purification Kit EUDAMED
- Model / Reference
- 1060089 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500316 EUDAMED
- Basic UDI-DI
- 069370445nacie1060182YP EUDAMED
- Direct Marketing DI
- 06937044500316 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 | 069370445nacie1060182YP | 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 (1)
- EUDAMED 67ddd911-e9e5-4d11-8895-7571edc6dff3 61 fields · synced Jun 18, 2026