Identity
- Trade Name
- Extended ViralTrans EUDAMEDKaiBiLi Extended ViralTrans FDA UDI
- Generic Name
- General specimen container IVD, additive/medium FDA UDI
- Device Name
- Extended ViralTrans EUDAMED3 mL viral transport medium/vial, with a regular swab FDA UDI
- Model / Reference
- M221007 EUDAMEDFDA UDI
- Description
- 3 mL viral transport medium/vial, with a regular swab FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16972698600316 EUDAMEDFDA UDI
- Basic UDI-DI
- 697269860VTM001YK EUDAMED
- Unit of Use DI
- 06972698600319 EUDAMED
- FDA Product Code
- JSM FDA UDI
- EMDN Code
- W01040499 VIRAL CULTURE REAGENTS - OTHER EUDAMED
- GMDN Term
- General specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2390 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Extended ViralTrans by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697269860VTM001YK | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013495
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED ff75aded-d9a9-4ea0-b5ca-7ac7d56e5344 61 fields · synced Jul 21, 2026
- FDA UDI 53907d55-084c-494a-a506-859cac89af8f 33 fields · synced May 30, 2026