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Disposable Suction Irrigation Set
EUDAMEDClass IIa (EU MDR)
Ref ASI-0037-000Model ASI-0002-000, ASI-0037-000, ASI-0038-000, ASI-0039-000
Identity
- Device Name
- Disposable Suction Irrigation Set EUDAMED
- Model / Reference
- ASI-0002-000, ASI-0037-000, ASI-0038-000, ASI-0039-000 EUDAMEDASI-0037-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975833140770 EUDAMED
- Basic UDI-DI
- 697583314SIS0038WP EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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 Suction Irrigation Set by Dongguan Senmed Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697583314SIS0038WP | Class IIa | 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 30a34aa4-dc05-4d26-8674-b61691781114 61 fields · synced Jun 19, 2026