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Disposable Pulse Lavage
EUDAMEDClass IIa (EU MDR)
Ref EP18-01, EP18-02, EP18-03
Identity
- Trade Name
- Disposable Pulse Lavage EUDAMED
- Device Name
- Disposable Pulse Lavage EUDAMED
- Model / Reference
- EP18-01, EP18-02, EP18-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-EP18JR EUDAMED
- Basic UDI-DI
- B-EP18JR EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Disposable Pulse Lavage by Beijing ZKSK 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-EP18JR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing ZKSK Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010403
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 6866233b-6d11-4aff-8f24-91af4bab2c5a 61 fields · synced Oct 7, 2026
- EUDAMED 6866233b-6d11-4aff-8f24-91af4bab2c5a-1 61 fields · synced Jun 10, 2026