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Single Use Endoscopic Linear Cutter Stapler and Reloads
EUDAMEDClass IIb (EU MDR)
Ref ELCRA60MModel ELCRA30M
Identity
- Device Name
- Single Use Endoscopic Linear Cutter Stapler and Reloads EUDAMED
- Model / Reference
- ELCRA30M EUDAMEDELCRA60M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971062276549 EUDAMED
- Basic UDI-DI
- 697106227ELCRH3 EUDAMED
- EMDN Code
- H020301050199 SINGLE PATIENT ARTICULATED LINEAR STAPLERS WITH BLADE FOR VIDEOSURGERY – OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 Endoscopic Linear Cutter 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 | 697106227ELCRH3 | 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 76190942-a3cb-4207-ac68-1fd949eb6ffd 61 fields · synced Oct 7, 2026