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60mm Endo Articulating Reloading Unit 3.5mm Blue
EUDAMEDClass IIb (EU MDR)
Ref PS9ECAR60BModel TF-1049
Identity
- Trade Name
- 60mm Endo Articulating Reloading Unit 3.5mm Blue EUDAMED
- Device Name
- Endoscopic Linear Cutter Stapler Reloading Unit EUDAMED
- Model / Reference
- TF-1049 EUDAMEDPS9ECAR60B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223027003 EUDAMED
- Basic UDI-DI
- B-05051223027003 EUDAMED
- EMDN Code
- H020301040102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR LAPAROSCOPY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
60mm Endo Articulating Reloading Unit 3.5mm Blue 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-05051223027003 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 91844bdd-6700-4498-a183-520eb374a56b 61 fields · synced Jun 18, 2026