Identity
- Trade Name
- STI Sample Preservation Buffer EUDAMED
- Device Name
- STI Sample Preservation Buffer EUDAMED
- Model / Reference
- PSTI01C-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979469760357 EUDAMED
- Basic UDI-DI
- 6979469760357MM EUDAMED
- EMDN Code
- W0104010204 SAMPLE TRANSPORT FOR NA TESTING 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
STI Sample Preservation Buffer 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 | 6979469760357MM | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
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 b444fccb-1133-44c6-8e9a-6c2f29da8830 61 fields · synced Jun 11, 2026