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Disposable Suction & Irrigation Unit
EUDAMEDClass IIa (EU MDR)
Ref F04301Ref F04102Ref F04101Ref F04302Ref F04001Ref F04002
Identity
- Device Name
- Disposable Suction & Irrigation Unit EUDAMED
- Model / Reference
- F04301 EUDAMEDF04102 EUDAMEDF04101 EUDAMEDF04302 EUDAMEDF04001 EUDAMEDF04002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937893905225 EUDAMED06937893900046 EUDAMED06937893900039 EUDAMED06937893905232 EUDAMED06937893900015 EUDAMED06937893900022 EUDAMED
- Basic UDI-DI
- 69378939F0462 EUDAMED
- EMDN Code
- A0601010299 DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Disposable Suction & Irrigation Unit by Tonglu Qianyan Medtech 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 | 69378939F0462 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tonglu Qianyan Medtech Co., Ltd
- EUDAMED SRN
- CN-MF-000017342
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (6)
- EUDAMED 3b535ca4-0412-4d3c-b5dd-d44e4e8cdfc3 61 fields · synced Jul 29, 2026
- EUDAMED 7a74f753-ea1a-47ab-ae30-34cacc596784 61 fields · synced May 18, 2026
- EUDAMED e5706a98-7e9d-4049-abdc-0887c39edaa9 61 fields · synced May 18, 2026
- EUDAMED cb0cfe05-c4e3-4ed0-bf31-de583ab0ee3b 61 fields · synced May 18, 2026
- EUDAMED 07d33e9e-ab3a-4dd1-9b1e-6fb0585115b1 61 fields · synced May 18, 2026
- EUDAMED 3a88e9ed-c8bf-440a-b5c9-d820002c3520 61 fields · synced May 19, 2026