Identity
- Trade Name
- APEXPULSE EUDAMEDiTool® ApexpulseTM EUDAMED
- Device Name
- DISPOSABLE PULSE LAVAGE EUDAMED
- Model / Reference
- 201-05-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16957277200101 EUDAMED
- Basic UDI-DI
- B-16957277200101 EUDAMED695727722010500TU 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
Apexpulse 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 Unknown
CE/MDR
European Union Unknown
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-16957277200101 | Class IIa | Unknown |
| EUDAMED | European Union | CE/MDD | B-16957277200101 | Class IIa | Unknown |
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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 aa508b56-3c7a-497d-8ee7-e63fa93b7334 61 fields · synced Jul 13, 2026
- EUDAMED 1aecdd55-95f9-4883-9d67-606221f16500 61 fields · synced May 17, 2026