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Pulsar II AWI
EUDAMEDClass IIa (EU MDR)
Ref 209-00-64Ref 209-04Ref 209-00-43Ref 209-00-50Ref 209-00-47Ref 209-05Ref 209-00-68Ref 209-00-51Ref 209-01
Identity
- Trade Name
- Pulsar II AWI EUDAMED
- Device Name
- Disposable Irrigation Adaptor EUDAMEDDisposable Pulse Irrigation Kit EUDAMEDDisposable Irrigation Tip EUDAMED
- Model / Reference
- 209-00-64 EUDAMED209-04 EUDAMED209-00-43 EUDAMED209-00-50 EUDAMED209-00-47 EUDAMED209-05 EUDAMED209-00-68 EUDAMED209-00-51 EUDAMED209-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972130470354 EUDAMED16972130470279 EUDAMED16972130470309 EUDAMED16972130470323 EUDAMED16972130470316 EUDAMED16972130470286 EUDAMED16972130470347 EUDAMED16972130470330 EUDAMED16972130470248 EUDAMED
- Basic UDI-DI
- B-16972130470354 EUDAMEDB-16972130470279 EUDAMEDB-16972130470309 EUDAMEDB-16972130470323 EUDAMEDB-16972130470316 EUDAMEDB-16972130470286 EUDAMEDB-16972130470347 EUDAMEDB-16972130470330 EUDAMEDB-16972130470248 EUDAMED
- EMDN Code
- A0380 TUBULAR DEVICES - ACCESSORIES EUDAMEDA03040299 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-16972130470354 | 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 (9)
- EUDAMED 2d0899d9-9a48-4b6d-84cf-c87c444dffe8 61 fields · synced Oct 6, 2026
- EUDAMED a58cda0d-62ed-45b0-a946-076816d94acf 61 fields · synced May 16, 2026
- EUDAMED e82587b3-3049-4ab3-aac8-1c4d05487579 61 fields · synced May 16, 2026
- EUDAMED 4f7d1f5f-b84b-41f4-900a-ba0ed4078426 61 fields · synced May 17, 2026
- EUDAMED fa27714f-43d4-4c11-acde-222150dfbdaf 61 fields · synced May 17, 2026
- EUDAMED 7c34fb69-26e9-4197-9689-2fed6b18f511 61 fields · synced May 17, 2026
- EUDAMED c4e6cef7-c46c-4c7d-b09e-7e7c314f4e91 61 fields · synced May 18, 2026
- EUDAMED 6748336e-e859-417d-abb5-3f0f5d7cc20d 61 fields · synced May 18, 2026
- EUDAMED 09bd7fb1-0c33-401b-bbfe-3005aa32c6d7 61 fields · synced May 19, 2026