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Disposable Linear Cutter Stapler and Reload
EUDAMEDClass IIb (EU MDR)
Ref BLBJ1003
Identity
- Device Name
- Disposable Linear Cutter Stapler and Reload EUDAMED
- Model / Reference
- BLBJ1003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949298912159 EUDAMED
- Basic UDI-DI
- B-06949298912159 EUDAMED
- EMDN Code
- H020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Czechia 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.
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- 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-06949298912159 | 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 (1)
- EUDAMED d7c00a3c-4d93-4af2-86af-f672eb72a99c 61 fields · synced Jun 18, 2026