iTool® ApexpulseTM

EUDAMED

Class IIa (EU MDR)

Ref 201-03-00

by Apex (Guangzhou) Tools & Orthopedics Co.

Identity

Trade Name: iTool® ApexpulseTM EUDAMED
APEXPULSE EUDAMED
Device Name: Disposable pulse Lavage EUDAMED
Model / Reference: 201-03-00 EUDAMED

Identifiers

Primary DI / UDI-DI: 16957277200088 EUDAMED
Basic UDI-DI: 695727722010300TJ EUDAMED
B-16957277200088 EUDAMED
EMDN Code: A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Germany EUDAMED
Spain EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

iTool® ApexpulseTM 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 Unknown

CE/MDD

European Union Unknown

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	695727722010300TJ	Class IIa	Unknown
EUDAMED	European Union	CE/MDR	695727722010300TJ	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 c065e02c-5ebf-42a6-b99d-b674c4a6648f 61 fields · synced Jun 12, 2026
EUDAMED 310f5d61-cc60-480b-a03e-ca4ae1cc28a5 61 fields · synced May 17, 2026