← Back to catalogue
YALEPIC® Urine Cell-Free DNA Storage Tube
EUDAMEDClass A (EU MDR)
Ref 10 ml Model 10 ml, 50 ml, 100 ml.
by Yali Biotech
Identity
- Device Name
- YALEPIC® Urine Cell-Free DNA Storage Tube EUDAMED
- Model / Reference
- 10 ml, 50 ml, 100 ml. EUDAMED10 ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978261340040 EUDAMED
- Basic UDI-DI
- 697826134YLUCDSTET EUDAMED
- EMDN Code
- W05010202 URINE COLLECTION, TUBES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
YALEPIC® Urine Cell-Free DNA Storage Tube by Yali Biotech — 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 | 697826134YLUCDSTET | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yali Biotech
- EUDAMED SRN
- CN-MF-000046226
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6f3a6780-d2b3-4052-855f-7c77ccf9a463 61 fields · synced Jul 12, 2026