Identity
- Trade Name
- Pulsar II™ AWI™ EUDAMEDPulsar II AWI EUDAMED
- Device Name
- Disposable pulse irrigation kits EUDAMED
- Model / Reference
- 209-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16957277200927 EUDAMED
- Basic UDI-DI
- 6957277220900CL EUDAMEDB-16957277200927 EUDAMED
- Direct Marketing DI
- 16957277200927 EUDAMED
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMEDA03040299 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
Category: Negative-pressure wound therapy system canister
Pulsar II™ AWI™ by Apex (Guangzhou) Tools & Orthopedics Co. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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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 | 6957277220900CL | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6957277220900CL | 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 5c6827bb-e09c-449e-8683-e401c1be5b7c 61 fields · synced Jul 13, 2026
- EUDAMED dd0e5b60-5b29-4468-b162-29798306d32d 61 fields · synced May 17, 2026