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Monopolar LapClinch with On/Off Ratchet, 5mm/33cm
EUDAMEDClass IIb (EU MDR)
Ref PS4554PNSModel TF-1036
Identity
- Trade Name
- Monopolar LapClinch with On/Off Ratchet, 5mm/33cm EUDAMED
- Device Name
- Monopolar Lapclinch EUDAMED
- Model / Reference
- TF-1036 EUDAMEDPS4554PNS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 35051223029862 EUDAMED
- Basic UDI-DI
- B-35051223029862 EUDAMED
- EMDN Code
- K0201010602 LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Monopolar LapClinch with On/Off Ratchet, 5mm/33cm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK…
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-35051223029862 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED be1fc8f1-8f4d-419e-bf56-0e5602052682 61 fields · synced Oct 6, 2026