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Disposable Powered Endoscopic Linear Cutting Stapler
EUDAMEDClass IIb (EU MDR)
Ref ECRC60YModel ECR60K, ECR60G, ECR60Y, ECR60B, ECR60W, ECR60K2, ECR60P2, ECR60W2, ECR45K, ECR45G, ECR45Y, ECR45B, ECR45W, ECR45K2, ECR45P2, ECR30B, ECR30W; ECRC60G, ECRC60Y, ECRC60B, ECRC60W, ECRC45G, ECRC45Y, ECRC45B, ECRC45W, ECRC30B, ECRC30W
Identity
- Trade Name
- Disposable Powered Endoscopic Linear Cutting Stapler EUDAMED
- Device Name
- Disposable Powered Endoscopic Linear Cutting Stapler EUDAMED
- Model / Reference
- ECR60K, ECR60G, ECR60Y, ECR60B, ECR60W, ECR60K2, ECR60P2, ECR60W2, ECR45K, ECR45G, ECR45Y, ECR45B, ECR45W, ECR45K2, ECR45P2, ECR30B, ECR30W; ECRC60G, ECRC60Y, ECRC60B, ECRC60W, ECRC45G, ECRC45Y, ECRC45B, ECRC45W, ECRC30B, ECRC30W EUDAMEDECRC60Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971418903393 EUDAMED
- Basic UDI-DI
- 69714189001128M EUDAMED
- EMDN Code
- H020201020102,H020301050101,H020301050102 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
Disposable Powered Endoscopic Linear Cutting Stapler by IntoCare Medical Technology (Suzhou) Co., Ltd. — 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 | 69714189001128M | Class IIb | Active |
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Manufacturer
- Manufacturer
- IntoCare Medical Technology (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000017686
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED e6b4880e-fb77-4d16-956a-559ef37757db 61 fields · synced Jun 19, 2026