Identity
- Device Name
- Single-Use Tubing Set (SUTS) EUDAMED
- Model / Reference
- 5201-67 EUDAMED5201-63 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05905771581817 EUDAMED05907595122481 EUDAMED
- Basic UDI-DI
- 5907595122PV-5201SUTS13Y EUDAMED5907595122PV-5201SUTSB9 EUDAMED
- EMDN Code
- A030499 ADMINISTRATION KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMEDEUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Single-Use Tubing Set (SUTS) by Vimex Sp. z o.o. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5907595122PV-5201SUTS13Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Vimex Sp. z o.o.
- EUDAMED SRN
- PL-MF-000008668
Sources (2)
- EUDAMED 32207b62-de7f-45cb-86d2-0e0f54745aa1 61 fields · synced Jul 31, 2026
- EUDAMED a4891c8c-0891-4848-88bf-eb9607604ccb 61 fields · synced Jul 31, 2026