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5mm x 440mm probe for PS3850ULT/PS3851ULT Laparoscopic Suction/Irrigation Set
EUDAMEDClass IIa (EU MDR)
Ref PS3845ULTNSModel TF1034
Identity
- Trade Name
- 5mm x 440mm probe for PS3850ULT/PS3851ULT Laparoscopic Suction/Irrigation Set EUDAMED
- Device Name
- ULTIMATE LAPAROSCOPIC SI SETS & PROBES EUDAMED
- Model / Reference
- TF1034 EUDAMEDPS3845ULTNS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 35051223028575 EUDAMED
- Basic UDI-DI
- B-35051223028575 EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
5mm x 440mm probe for PS3850ULT/PS3851ULT Laparoscopic Suction/Irrigation Set by Purple Surgical Holdings Limited also known as Purple Surgical International…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-35051223028575 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 54f62019-348f-4ef5-94a7-027b15d41b3e 61 fields · synced Oct 9, 2026