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Linear Stapler Reloading Unit 90 × 4.8 mm
EUDAMEDClass IIb (EU MDR)
Ref PS9LSR90GModel TF-1045
Identity
- Trade Name
- Linear Stapler Reloading Unit 90 × 4.8 mm EUDAMED
- Device Name
- Linear Stapler Reloading Unit EUDAMED
- Model / Reference
- TF-1045 EUDAMEDPS9LSR90G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051223023265 EUDAMED
- Basic UDI-DI
- B-05051223023265 EUDAMED
- EMDN Code
- H020201010102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Linear Stapler Reloading Unit 90 × 4.8 mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited…
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-05051223023265 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000012819
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 1896919d-bf47-4178-a015-4bcb1e021beb 61 fields · synced Oct 6, 2026