Identity
- Trade Name
- APEX PULSE EUDAMEDiTool® ApexpulseTM EUDAMED
- Device Name
- DISPOSABLE PULSE LAVAGE EUDAMED
- Model / Reference
- 201-04-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16957277200095 EUDAMED
- Basic UDI-DI
- B-16957277200095 EUDAMED695727722010400TP EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDGermany 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
Apex Pulse by Apex (Guangzhou) Tools & Orthopedics Co. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-16957277200095 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-16957277200095 | 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 b01c571a-3e97-497a-b1b6-cf005d8644a2 61 fields · synced Oct 5, 2026
- EUDAMED a2cd386d-7b66-4fe0-9c27-ed79044f219e 61 fields · synced May 17, 2026