Identity
- Trade Name
- Urine Sample Collector EUDAMED
- Device Name
- Urine Sample Collector EUDAMED
- Model / Reference
- N101E-40T EUDAMEDN101E-1T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792714564 EUDAMED06955792714557 EUDAMED
- Basic UDI-DI
- 69557927N101E0000001DA EUDAMED
- EMDN Code
- W0105900299 INFECTIOUS IMMUNOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Urine Sample Collector by Sansure Biotech Inc. — 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 | 69557927N101E0000001DA | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 1ad24129-5797-4b51-8726-9b5af0db02a4 61 fields · synced Aug 3, 2026
- EUDAMED 85dbd2f9-2051-4a9b-8eb9-d23c530b4c67 61 fields · synced May 17, 2026