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Disposable Sterilized Laparoscopic Surgical Instruments Camera Drape
EUDAMEDClass I (EU MDR)
Ref ACS-0013-000Model ACS-0001-000, ACS-0005-000, ACS-0012-000, ACS-0017-000, ACS-0039-000
Identity
- Device Name
- Disposable Sterilized Laparoscopic Surgical Instruments Camera Drape EUDAMED
- Model / Reference
- ACS-0001-000, ACS-0005-000, ACS-0012-000, ACS-0017-000, ACS-0039-000 EUDAMEDACS-0013-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975833142187 EUDAMED
- Basic UDI-DI
- 697583314CD00058Z EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER 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
Disposable Sterilized Laparoscopic Surgical Instruments Camera Drape by Dongguan Senmed Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 697583314CD00058Z | 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 49127885-cc56-4e8c-91da-f1a6a901ba8d 61 fields · synced Jun 19, 2026