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Suction Irrigation Set
EUDAMEDClass IIa (EU MDR)
Ref ASI2450TBModel ASI-A20000, ASI-A20010, ASI-A25000, ASI-A27000, ASI-A2700Z, ASI-B20000, ASI-B20030, ASI-C20060, ASI-C2006Z, ASI-0X50X0, ASI-0X70X0, ASI-0X90X0, ASI-1X00X0, ASI-1X50X0, ASI-1X70X0, ASI-2X10X0, ASI-2X50X0, ASI-3X00X0
Identity
- Trade Name
- Suction Irrigation Set EUDAMED
- Device Name
- Suction Irrigation Set EUDAMED
- Model / Reference
- ASI-A20000, ASI-A20010, ASI-A25000, ASI-A27000, ASI-A2700Z, ASI-B20000, ASI-B20030, ASI-C20060, ASI-C2006Z, ASI-0X50X0, ASI-0X70X0, ASI-0X90X0, ASI-1X00X0, ASI-1X50X0, ASI-1X70X0, ASI-2X10X0, ASI-2X50X0, ASI-3X00X0 EUDAMEDASI2450TB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711605995290 EUDAMED
- Basic UDI-DI
- 471160599ASI016Q EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Suction Irrigation Set by Advanced Medical Design 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 | 471160599ASI016Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advanced Medical Design Co., Ltd.
- EUDAMED SRN
- TW-MF-000019772
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED a50bee6c-ee9e-4384-a002-5a132cece274 61 fields · synced Jul 17, 2026