Identity
- Trade Name
- Pulsar II AWI EUDAMED
- Device Name
- Disposable Pulse Irrigation Kit EUDAMED
- Model / Reference
- 209-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972130470255 EUDAMED
- Basic UDI-DI
- B-16972130470255 EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Pulsar II AWI by Apex (Suzhou) Medical Products Company — 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-16972130470255 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Apex (Suzhou) Medical Products Company
- EUDAMED SRN
- CN-MF-000031975
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 84b53a92-c8e3-4c02-8a85-03730b8c9ed9 61 fields · synced Jun 18, 2026