Identity
- Trade Name
- Virus RNA Collection Kit EUDAMED
- Device Name
- IVD Sample Collection Kit EUDAMED
- Model / Reference
- 401120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956299701385 EUDAMED
- Basic UDI-DI
- 695629970005P7 EUDAMED
- Direct Marketing DI
- 06956299701385 EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM 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
Category: General-purpose absorbent tip applicator/swab, single-use
Virus RNA Collection Kit by Xiamen Zeesan Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 e5510c60-bb05-4e52-bcc9-517a8de03c0f 61 fields · synced Jul 16, 2026