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AutoShield Trocar, Threaded, 5x100mm
EUDAMEDClass IIa (EU MDR)
Ref PS5565ULTNSModel TF-1020
Identity
- Trade Name
- AutoShield Trocar, Threaded, 5x100mm EUDAMED
- Device Name
- Autoshield Trocar EUDAMED
- Model / Reference
- TF-1020 EUDAMEDPS5565ULTNS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 35051223032138 EUDAMED
- Basic UDI-DI
- B-35051223032138 EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa 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
AutoShield Trocar, Threaded, 5x100mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and…
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-35051223032138 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 164d6da8-15e4-48ca-97ee-eea805795ea2 61 fields · synced Oct 6, 2026