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Monopolar LapClinch with Ratchet, 5mm x 33cm
EUDAMEDClass IIb (EU MDR)
Ref PS4554NSModel Tf-1036Ref PS4554Model TF-1036
Identity
- Trade Name
- Monopolar LapClinch with Ratchet, 5mm x 33cm EUDAMED
- Device Name
- Monopolar Lapclinch EUDAMED
- Model / Reference
- Tf-1036 EUDAMEDPS4554NS EUDAMEDPS4554 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 35051223029763 EUDAMED05051223027478 EUDAMED
- Basic UDI-DI
- B-35051223029763 EUDAMEDB-05051223027478 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
EUDAMEDEUDAMED
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 Ratchet, 5mm x 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-35051223029763 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e9c1430f-ae81-4691-9854-5d7cb3309b35 61 fields · synced Oct 9, 2026
- EUDAMED f7f8320b-eff9-4ac0-80d5-675251bc2e75 61 fields · synced May 19, 2026