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Disposable Sterilized Laparoscopic Surgical Instruments Sharps Holder
EUDAMEDClass I (EU MDR)
Ref ANC-0003-000Model ASB-0001-000, ASB-0004-000, ASB-0006-000, ASB-0009-000, ASB-0010-000
Identity
- Device Name
- Disposable Sterilized Laparoscopic Surgical Instruments Sharps Holder EUDAMED
- Model / Reference
- ASB-0001-000, ASB-0004-000, ASB-0006-000, ASB-0009-000, ASB-0010-000 EUDAMEDANC-0003-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975833142392 EUDAMED
- Basic UDI-DI
- 697583314SMB0004RX EUDAMED
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical retractor/retraction system blade, single-use
Disposable Sterilized Laparoscopic Surgical Instruments Sharps Holder by Dongguan Senmed Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED
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Also classified as Surgical retractor/retraction system blade, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697583314SMB0004RX | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Senmed Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028972
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 000b20f1-fd6d-412b-a37e-da52e781c10b 61 fields · synced Jun 18, 2026