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High-throughput Virus DNA/RNA Nucleic Acid Extraction Kit
EUDAMEDClass A (EU MDR)
Ref RM502ME
Identity
- Device Name
- High-throughput Virus DNA/RNA Nucleic Acid Extraction Kit EUDAMED
- Model / Reference
- RM502ME EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315738729 EUDAMED
- Basic UDI-DI
- 6973315738729BK EUDAMED
- Direct Marketing DI
- 06973315738729 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
High-throughput Virus DNA/RNA Nucleic Acid Extraction Kit by Nanjing Vazyme Medical Technology 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 | 6973315738729BK | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e3256881-2367-4183-b116-ea26713d15ed 61 fields · synced Jun 18, 2026