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Single Use Surgical Suction Irrigator
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref TD-CE-02Model JM-CX4BRef TD-SI Rev.01Model JM-CX1A
Identity
- Device Name
- Single Use Surgical Suction Irrigator EUDAMED
- Model / Reference
- JM-CX4B EUDAMEDTD-CE-02 EUDAMEDJM-CX1A EUDAMEDTD-SI Rev.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956989950086 EUDAMED06956989950024 EUDAMED
- Basic UDI-DI
- B-06956989950086 EUDAMEDB-06956989950024 EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Single Use Surgical Suction Irrigator by Jiangsu Haize Medical Scientific Development Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161421 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06956989950086 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000039134
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED 55e8456b-de93-4fca-b66b-9652154a9675 61 fields · synced Oct 6, 2026
- EUDAMED d542af3a-6af5-4bcd-a73b-2b044de81d9e 61 fields · synced Jul 9, 2026
- FDA 510(k) K161421 1 fields · synced May 18, 2026