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Disposable Linear Cutter Staplers and Reloads
EUDAMEDClass IIb (EU MDR)
Ref DLC B-60BRef DLC A-80BRef DLC A-60GRef DCR A-100GRef DLC A-60BRef DCR B-80GRef DCR B-100BRef DLC B-80GRef DLC A-80GRef DLC A-100BRef DCR B-80BRef DCR A-80GRef DCR A-100BRef DLC B-60G
Identity
- Trade Name
- Disposable Linear Cutter Staplers and Reloads EUDAMED
- Device Name
- Disposable Linear Cutter Staplers and Reloads EUDAMED
- Model / Reference
- DLC B-60B EUDAMEDDLC A-80B EUDAMEDDLC A-60G EUDAMEDDCR A-100G EUDAMEDDLC A-60B EUDAMEDDCR B-80G EUDAMEDDCR B-100B EUDAMEDDLC B-80G EUDAMEDDLC A-80G EUDAMEDDLC A-100B EUDAMEDDCR B-80B EUDAMEDDCR A-80G EUDAMEDDCR A-100B EUDAMEDDLC B-60G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946480508633 EUDAMED06946480507834 EUDAMED06946480507643 EUDAMED06946480567142 EUDAMED06946480507636 EUDAMED06946480568842 EUDAMED06946480568132 EUDAMED06946480508848 EUDAMED06946480507841 EUDAMED06946480507131 EUDAMED06946480568835 EUDAMED06946480567845 EUDAMED06946480567135 EUDAMED06946480508640 EUDAMED
- Basic UDI-DI
- B-06946480508633 EUDAMEDB-06946480507834 EUDAMEDB-06946480507643 EUDAMEDB-06946480567142 EUDAMEDB-06946480507636 EUDAMEDB-06946480568842 EUDAMEDB-06946480568132 EUDAMEDB-06946480508848 EUDAMEDB-06946480507841 EUDAMEDB-06946480507131 EUDAMEDB-06946480568835 EUDAMEDB-06946480567845 EUDAMEDB-06946480567135 EUDAMEDB-06946480508640 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
EUDAMEDEUDAMED
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 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
- 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-06946480508633 | 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 (14)
- EUDAMED c99f6371-a28e-4fb0-baa0-a0ada03cafda 61 fields · synced Aug 3, 2026
- EUDAMED 810fe46e-4334-4501-baa9-ac62334dca2c 61 fields · synced May 16, 2026
- EUDAMED 9341a076-68ee-4c55-815a-0f0db28e9f94 61 fields · synced May 16, 2026
- EUDAMED c24a389b-a9c0-4e59-9dea-33a1f7e89ec2 61 fields · synced May 16, 2026
- EUDAMED bef96c99-8e99-43d1-80a9-ebff499d3836 61 fields · synced May 17, 2026
- EUDAMED f4b3ab9a-08fc-4de3-8cf2-fcd1299d4cd5 61 fields · synced May 17, 2026
- EUDAMED d04816ff-879f-4001-b5c5-59b367e14342 61 fields · synced May 17, 2026
- EUDAMED 5234c0da-f086-426b-83c0-bd0dc041f2e3 61 fields · synced May 17, 2026
- EUDAMED 7639f0a0-a816-4182-8950-d2fe01f9eb37 61 fields · synced May 17, 2026
- EUDAMED a84aee18-9d97-4af5-b875-dc5ddf7c5544 61 fields · synced May 18, 2026
- EUDAMED b386d861-6e72-402c-a518-dce254e29bb4 61 fields · synced May 18, 2026
- EUDAMED d6316308-054a-4a1b-8904-311fb7fb4cda 61 fields · synced Jul 10, 2026
- EUDAMED fcd3db57-1b8f-47de-b121-680a11900ee1 61 fields · synced Jul 17, 2026
- EUDAMED 4c34ee18-8026-4a48-85f4-a35de776c854 61 fields · synced Jul 25, 2026