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Extended Flat Blade Electrode, 113 mm
EUDAMEDClass IIb (EU MDR)
Ref PS5006Model TF-1040
Identity
- Trade Name
- Extended Flat Blade Electrode, 113 mm EUDAMED
- Device Name
- Flat Blade Electrode EUDAMED
- Model / Reference
- TF-1040 EUDAMEDPS5006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223004394 EUDAMED
- Basic UDI-DI
- B-05051223004394 EUDAMED
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Extended Flat Blade Electrode, 113 mm 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-05051223004394 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED dbd8e7c1-e7b2-4c51-926c-890e1f397aa5 61 fields · synced Oct 6, 2026