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Single Use Transverse Cutting Linear Stapler and Reloads
EUDAMEDClass IIb (EU MDR)
Ref TCLS40BModel TCLS30WRef TCLS40WRef TCLS60B
Identity
- Device Name
- Single Use Transverse Cutting Linear Stapler and Reloads EUDAMED
- Model / Reference
- TCLS30W EUDAMEDTCLS40B EUDAMEDTCLS40W EUDAMEDTCLS60B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971062270455 EUDAMED06971062270417 EUDAMED06971062270448 EUDAMED06971062270479 EUDAMED
- Basic UDI-DI
- 697106227TCLSKU EUDAMED
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Single Use Transverse Cutting Linear Stapler and Reloads by Suzhou Lantex Medical Technology Company Limited — Class IIb — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697106227TCLSKU | Class IIb | Active |
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Manufacturer
- Manufacturer
- Suzhou Lantex Medical Technology Company Limited
- EUDAMED SRN
- CN-MF-000039444
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED 025204a6-2e89-4185-b156-4a1015662f96 61 fields · synced Oct 5, 2026
- EUDAMED 06c98982-b218-437d-ab8e-1055c72e1490 61 fields · synced May 17, 2026
- EUDAMED 44c09b5c-1d8c-4015-8053-c9c92067cd6e 61 fields · synced May 18, 2026
- EUDAMED c1cd3697-44d6-4bd9-8b4a-6a962d9842b2 61 fields · synced May 18, 2026