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Virus Sample Stabilizer
EUDAMEDClass A (EU MDR)
Ref R513-01Model R513Ref R513-02
Identity
- Trade Name
- Virus Sample Stabilizer EUDAMED
- Device Name
- Virus Sample Stabilizer EUDAMED
- Model / Reference
- R513-01 EUDAMEDR513 EUDAMEDR513-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739795 EUDAMED06973315739801 EUDAMED
- Basic UDI-DI
- 6973315739795C7 EUDAMED
- Direct Marketing DI
- 06973315739795 EUDAMED06973315739801 EUDAMED
- EMDN Code
- W0104010206 MEDIA IN TUBES (SOLID & LIQUID) 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
Virus Sample Stabilizer by Nanjing Vazyme Medical Technology 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 | 6973315739795C7 | 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 (3)
- EUDAMED 4f419e1a-c90b-4cb5-babc-eb0a2f840f7f 61 fields · synced Oct 6, 2026
- EUDAMED 91657111-6eb0-40ec-8736-d6ebcb75c286 61 fields · synced Jun 19, 2026
- EUDAMED d9920174-96a3-4d00-853c-ffb0c3be0612 61 fields · synced Aug 4, 2026