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Single Use Transverse Cutting Linear Stapler and Reloads
EUDAMEDClass IIb (EU MDR)
Ref TCLS30BModel TCLS30W
Identity
- Device Name
- Single Use Transverse Cutting Linear Stapler and Reloads EUDAMED
- Model / Reference
- TCLS30W EUDAMEDTCLS30B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971062270424 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
Category: Open-surgery manual linear cutting stapler, single-use
Single Use Transverse Cutting Linear Stapler and Reloads by Suzhou Lantex Medical Technology Company Limited — Class IIb — MDR — listed in EUDAMED
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Also classified as Open-surgery manual linear cutting stapler, single-use.
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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 (1)
- EUDAMED 035760f2-1647-48f2-b815-285286774b36 61 fields · synced Jun 18, 2026