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Sterile single use suction irrigation tubing set
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref WSI105330NModel -Ref WSI105280TRef SI0005Ref WSI105330T（PS3800E）Ref WSI105330JRef WSI105330LRef WSI105450TRef WSI105330T
by WickiMed (HuiZhou) Medical Equipment Manufacturing Co., Ltd
Identity
- Trade Name
- Sterile single use suction irrigation tubing set EUDAMEDPS3800E EUDAMED
- Device Name
- Sterile single use suction irrigation tubing set EUDAMED
- Model / Reference
- - EUDAMEDWSI105330N EUDAMEDWSI105280T EUDAMEDSI0005 EUDAMEDWSI105330T（PS3800E） EUDAMEDWSI105330J EUDAMEDWSI105330L EUDAMEDWSI105450T EUDAMEDWSI105330T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970739454624 EUDAMED06970739454556 EUDAMED06970739454587 EUDAMED06970739454563 EUDAMED06970739454617 EUDAMED06970739454600 EUDAMED06970739454570 EUDAMED
- Basic UDI-DI
- 697073945TD009K4 EUDAMED
- EMDN Code
- A06010103 CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDGermany EUDAMEDItaly 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
Sterile single use suction irrigation tubing set by WickiMed (HuiZhou) Medical Equipment Manufacturing Co., Ltd — Class IIa — FDA_510K, MDR — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172794 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697073945TD009K4 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000027477
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (9)
- EUDAMED 11cae84b-7f88-4567-b6ff-5434183b3d09 61 fields · synced Oct 6, 2026
- EUDAMED 0f192bc8-8c4b-42f1-8e35-c1287dc34570 61 fields · synced May 16, 2026
- EUDAMED 48ad7615-c95b-4ad3-b855-a48d469847fa 61 fields · synced May 16, 2026
- EUDAMED 52006bb7-d0b5-4b98-a176-2421b0502a52 61 fields · synced May 17, 2026
- EUDAMED 1d22efd8-a1c3-43c9-8313-4bbee1c82023 61 fields · synced May 18, 2026
- EUDAMED a3429481-a334-4986-b278-4465722df1eb 61 fields · synced May 18, 2026
- EUDAMED 7956aa85-e033-41ff-9647-8277a40788af 61 fields · synced May 18, 2026
- EUDAMED 70631aa3-d301-46bf-beb6-dddf5f5f5abd 61 fields · synced Jul 30, 2026
- FDA 510(k) K172794 1 fields · synced May 18, 2026