Identity
- Trade Name
- Saliva RNA Sample Collection Kit EUDAMED
- Device Name
- IVD Sample Collection Kit EUDAMED
- Model / Reference
- 401115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956299701378 EUDAMED
- Basic UDI-DI
- 695629970005P7 EUDAMED
- Direct Marketing DI
- 06956299701378 EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Saliva RNA Sample Collection Kit by Xiamen Zeesan Biotech 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 | 695629970005P7 | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Zeesan Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000013246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED db1e3b7d-835b-4ae1-91fd-75003cce0e29 61 fields · synced Jul 14, 2026