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Disposable Powered Endoscopic Linear Cutting Stapler
EUDAMEDClass IIb (EU MDR)
Ref ECR60P2Model 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 EUDAMEDECR60P2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971418909012 EUDAMED
- Basic UDI-DI
- 69714189001128M EUDAMED
- EMDN Code
- H020201020102,H020301050101 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 90563bfb-ec11-4de7-b2eb-09e62fd42d93 61 fields · synced Jun 18, 2026