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Disposable Linear Cutter Stapler and Reload
EUDAMEDClass IIb (EU MDR)
Ref QAB1004Ref GH553Ref HF754Ref GK1004Ref BLBJ753Ref HF603Ref GH754Ref HAF454Ref BLBJ1002Ref QAB1003Ref GK1003Ref SAF454Ref GK1002Ref HAF753Ref BLBJ752Ref GH1003Ref BLBJ754Ref GK754Ref QAB802Ref GK753Ref GK552Ref QB1003Ref SF904Ref GK554Ref GH1004Ref QAB804Ref GH753Ref SF454Ref QB602
Identity
- Device Name
- Disposable Linear Cutter Stapler and Reload EUDAMEDDisposable Linear Staplers and Reloads EUDAMED
- Model / Reference
- QAB1004 EUDAMEDGH553 EUDAMEDHF754 EUDAMEDGK1004 EUDAMEDBLBJ753 EUDAMEDHF603 EUDAMEDGH754 EUDAMEDHAF454 EUDAMEDBLBJ1002 EUDAMEDQAB1003 EUDAMEDGK1003 EUDAMEDSAF454 EUDAMEDGK1002 EUDAMEDHAF753 EUDAMEDBLBJ752 EUDAMEDGH1003 EUDAMEDBLBJ754 EUDAMEDGK754 EUDAMEDQAB802 EUDAMEDGK753 EUDAMEDGK552 EUDAMEDQB1003 EUDAMEDSF904 EUDAMEDGK554 EUDAMEDGH1004 EUDAMEDQAB804 EUDAMEDGH753 EUDAMEDSF454 EUDAMEDQB602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949298915228 EUDAMED06949298912104 EUDAMED06949298932133 EUDAMED06949298930221 EUDAMED06949298912142 EUDAMED06949298932027 EUDAMED06949298912210 EUDAMED06949298910216 EUDAMED06949298912050 EUDAMED06949298915129 EUDAMED06949298930122 EUDAMED06949298914214 EUDAMED06949298930023 EUDAMED06949298910131 EUDAMED06949298912043 EUDAMED06949298912128 EUDAMED06949298912241 EUDAMED06949298930214 EUDAMED06949298915013 EUDAMED06949298930115 EUDAMED06949298930009 EUDAMED06949298930153 EUDAMED06949298933123 EUDAMED06949298930207 EUDAMED06949298912227 EUDAMED06949298915211 EUDAMED06949298912111 EUDAMED06949298933147 EUDAMED06949298930030 EUDAMED
- Basic UDI-DI
- B-06949298915228 EUDAMEDB-06949298912104 EUDAMEDB-06949298932133 EUDAMEDB-06949298930221 EUDAMEDB-06949298912142 EUDAMEDB-06949298932027 EUDAMEDB-06949298912210 EUDAMEDB-06949298910216 EUDAMEDB-06949298912050 EUDAMEDB-06949298915129 EUDAMEDB-06949298930122 EUDAMEDB-06949298914214 EUDAMEDB-06949298930023 EUDAMEDB-06949298910131 EUDAMEDB-06949298912043 EUDAMEDB-06949298912128 EUDAMEDB-06949298912241 EUDAMEDB-06949298930214 EUDAMEDB-06949298915013 EUDAMEDB-06949298930115 EUDAMEDB-06949298930009 EUDAMEDB-06949298930153 EUDAMEDB-06949298933123 EUDAMEDB-06949298930207 EUDAMEDB-06949298912227 EUDAMEDB-06949298915211 EUDAMEDB-06949298912111 EUDAMEDB-06949298933147 EUDAMEDB-06949298930030 EUDAMED
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMEDH020201010102 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITHOUT BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia EUDAMEDPoland 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 Stapler and Reload by Jiangsu Brightness Medical Devices Co., Ltd. — 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
- 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
- Disposable Linear Cutter Staplers and Reloads — Sinolinks Medical Innovation, Inc. · 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-06949298915228 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jiangsu Brightness Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000019184
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (29)
- EUDAMED 2c87e9ac-394c-4407-90c5-b7cd022a1fc1 61 fields · synced Aug 4, 2026
- EUDAMED 0a841e6b-bbb4-4476-87a6-1fb8912d2de8 61 fields · synced May 11, 2026
- EUDAMED 196a6d9e-66b2-43ea-86bd-0000b9ef4017 61 fields · synced May 11, 2026
- EUDAMED 63131583-218c-4e13-a560-3893d601d92e 61 fields · synced May 16, 2026
- EUDAMED 6d38d256-e305-4aa3-a109-2ad278a6220c 61 fields · synced May 16, 2026
- EUDAMED 5f1b451f-1fa0-4ed0-8ee9-efaf8fec6fa0 61 fields · synced May 16, 2026
- EUDAMED b3e2aa1f-cc93-4944-86d3-c31c40a75360 61 fields · synced May 17, 2026
- EUDAMED b89442a8-beb6-4e6e-ae96-c5289e4760f7 61 fields · synced May 17, 2026
- EUDAMED a1f41414-0267-4863-bac9-6cca708b5aff 61 fields · synced May 17, 2026
- EUDAMED 23308595-5fc5-4acb-aed7-b74db7fd8e5a 61 fields · synced May 17, 2026
- EUDAMED 39fe8e14-e331-4e52-8f8f-5b7a390b8679 61 fields · synced May 17, 2026
- EUDAMED ea966705-5812-4e14-a369-1f7f0d7a50f0 61 fields · synced May 17, 2026
- EUDAMED 7f0dd7a9-33e0-4ff4-b230-2a68928f9ea6 61 fields · synced May 17, 2026
- EUDAMED d634eba5-24fa-40a1-b2f5-70f08cab1d43 61 fields · synced May 17, 2026
- EUDAMED 9b5e7f3f-cc77-4fd2-840e-012571526d1c 61 fields · synced May 17, 2026
- EUDAMED 835faa97-00ab-467d-850a-81587483a19c 61 fields · synced May 17, 2026
- EUDAMED ac92f1ba-4581-405f-9a55-4235e848fbff 61 fields · synced May 18, 2026
- EUDAMED 4a092211-f338-4340-9c5e-62447ed63ede 61 fields · synced May 18, 2026
- EUDAMED 75ef3b6e-3486-46ec-8ce9-b605f4fb310a 61 fields · synced May 18, 2026
- EUDAMED 04fbd9bc-ef0d-417c-b339-80f4c8a49ac5 61 fields · synced May 18, 2026
- EUDAMED 13b19f38-623f-410b-9506-c4025133712a 61 fields · synced May 18, 2026
- EUDAMED fefbde06-3834-4c97-81c5-0ba4f82eae6c 61 fields · synced May 18, 2026
- EUDAMED ab9831ee-0ad1-4873-ad8a-81ace6411865 61 fields · synced May 18, 2026
- EUDAMED 308ed171-2af6-4edb-a068-43f2f6ec812b 61 fields · synced May 18, 2026
- EUDAMED 320247ed-32ba-48bb-a44d-de7d4740077b 61 fields · synced May 18, 2026
- EUDAMED 7790c9fd-d5cc-419f-a7bf-c6c4477c732b 61 fields · synced May 18, 2026
- EUDAMED 60e4069b-3431-4461-9d33-c7c8e5eb39b9 61 fields · synced May 19, 2026
- EUDAMED 88784521-bbd2-499e-9537-df60de0eff5b 61 fields · synced May 19, 2026
- EUDAMED 6700324f-dbb1-4650-b7b2-dc78d237d763 61 fields · synced May 19, 2026