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Disposable Linear Cutter Staplers and Reloads
EUDAMEDClass IIb (EU MDR)
Ref DLC B-80B
Identity
- Trade Name
- Disposable Linear Cutter Staplers and Reloads EUDAMED
- Device Name
- Disposable Linear Cutter Staplers and Reloads EUDAMED
- Model / Reference
- DLC B-80B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946480508831 EUDAMED
- Basic UDI-DI
- B-06946480508831 EUDAMED
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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 Linear Cutter Staplers and Reloads by Sinolinks Medical Innovation, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery manual linear cutting stapler, single-use.
- GIA — Covidien LP · Class II
- ZHY series of disposable auto linear stapler and cartridge — Changzhou Waston Medical Appliance Co., Ltd · Class IIb
- PROXIMATE — Ethicon Endo-Surgery, LLC · Class IIb
- Disposable Circumcision Staplers — Sinolinks Medical Innovation, Inc. · Class IIa
- Disposable Linear Cutter Stapler and Reload — Jiangsu Brightness Medical Devices Co.,Ltd. · Class IIb
- Disposable Linear Cutter Stapler and Reload — Jiangsu Brightness Medical Devices Co.,Ltd. · Class IIb
- Cartridge for Disposable Linear Cutter — Changzhou Waston Medical Appliance Co., Ltd · Class IIb
- Disposable Endoscopic Linear Cutter Staplers and Cartridges — ChangZhou 3R Medical Device Technology Co.,Ltd · Class IIb
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-06946480508831 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sinolinks Medical Innovation, Inc.
- EUDAMED SRN
- CN-MF-000010840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 84ae8fae-4124-489c-b597-de1f6aaf1035 61 fields · synced May 23, 2026