Identity
- Trade Name
- Pulsar II AWI EUDAMEDPulsar II™ AWI™ EUDAMED
- Device Name
- DISPOSABLE PULSE IRRIGATION KITS EUDAMED
- Model / Reference
- 209-02 EUDAMED209-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16957277200958 EUDAMED
- Basic UDI-DI
- B-16957277200958 EUDAMED6957277220900CL EUDAMED
- Direct Marketing DI
- 16957277200958 EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Pulsar II AWI by Apex (Guangzhou) Tools & Orthopedics Co. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16957277200958 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-16957277200958 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Apex (Guangzhou) Tools & Orthopedics Co.
- EUDAMED SRN
- CN-MF-000018403
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED ca8a9efe-b7ca-4a79-9362-014b851bc89f 61 fields · synced Jul 18, 2026
- EUDAMED 293c8bf6-2169-4e20-ba48-8d65c642af5a 61 fields · synced May 16, 2026