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Nucleic Acid Extraction Reagent
EUDAMEDClass A (EU MDR)
Ref LZD001-64JIIModel V1-D/R-64JⅠ
Identity
- Device Name
- Nucleic Acid Extraction Reagent EUDAMED
- Model / Reference
- V1-D/R-64JⅠ EUDAMEDLZD001-64JII EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975102440242 EUDAMED
- Basic UDI-DI
- 697510244LZD001FP EUDAMED
- Direct Marketing DI
- 06975102440242 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
- Germany 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 Reagent by Jiangsu Qitian Gene biotechnology 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 | 697510244LZD001FP | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Qitian Gene biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000050877
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ca9ae853-70f0-4211-8d8f-5f49b1c00f06 61 fields · synced Jun 18, 2026