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Disposable Endoscopic Linear Cutter Staplers and Cartridges
EUDAMEDClass IIb (EU MDR)
Ref SRDELC-B-S85
Identity
- Device Name
- Disposable Endoscopic Linear Cutter Staplers and Cartridges EUDAMED
- Model / Reference
- SRDELC-B-S85 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973118370508 EUDAMED
- Basic UDI-DI
- B-06973118370508 EUDAMED
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Open-surgery manual linear cutting stapler, single-use
Disposable Endoscopic Linear Cutter Staplers and Cartridges by ChangZhou 3R Medical Device Technology Co., Ltd — Class IIb — MDD — listed in EUDAMED
Similar devices
Also classified as Open-surgery manual linear cutting stapler, single-use.
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- Cartridge for Disposable Linear Cutter — Changzhou Waston Medical Appliance Co., Ltd · Class IIb
- Disposable Foreskin Stapler — Jiangsu Celtics MediTech Co.,Ltd. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973118370508 | Class IIb | Active |
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Manufacturer
- Manufacturer
- ChangZhou 3R Medical Device Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000001123
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 2a5363bc-49e6-44ee-b273-b25e29db5d6f 61 fields · synced Jun 19, 2026