Identity
- Trade Name
- Pulsed Lavage System, AC Power EUDAMED
- Device Name
- Surgical Lavage Units EUDAMED
- Model / Reference
- 2500 EUDAMED9750000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973181645565 EUDAMED
- Basic UDI-DI
- B-06973181645565 EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Pulsed Lavage System, AC Power by Dongguan Kaiser Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06973181645565 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan Kaiser Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000006968
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 32eef6d0-180d-4d15-8c0a-c393cf57e7d6 61 fields · synced Jun 17, 2026