← Back to catalogue

Apexpulse

EUDAMED

Class IIa (EU MDR)

Ref 201-00-52Ref 201-00-50Ref 201-00-37Ref 201-00-46

by Apex (Guangzhou) Tools & Orthopedics Co.

Identity

Trade Name
APEXPULSE EUDAMED
Device Name
FEMORAL BRUSH TIP EUDAMED
SHOWER SPRAY TIP EUDAMED
SHOWER SPRAY TIP WITH SPLASH SHIELD EUDAMED
FEMORAL SPRAY TIP EUDAMED
Model / Reference
201-00-52 EUDAMED
201-00-50 EUDAMED
201-00-37 EUDAMED
201-00-46 EUDAMED

Identifiers

Primary DI / UDI-DI
16957277200163 EUDAMED
16957277200149 EUDAMED
16957277200118 EUDAMED
16957277200132 EUDAMED
Basic UDI-DI
B-16957277200163 EUDAMED
B-16957277200149 EUDAMED
B-16957277200118 EUDAMED
B-16957277200132 EUDAMED
EMDN Code
A0380 TUBULAR DEVICES - ACCESSORIES 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Apexpulse by Apex (Guangzhou) Tools & Orthopedics Co. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Apex (Guangzhou) Tools & Orthopedics Co.
EUDAMED SRN
CN-MF-000018403
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (4)

  • EUDAMED 27fd4874-8727-47f7-8f9d-81b76b40f121 61 fields · synced Oct 6, 2026
  • EUDAMED f62646e4-3228-4217-9310-946020029bd9 61 fields · synced May 18, 2026
  • EUDAMED 1e490d46-89e1-4ce8-b773-fa82272a3f4e 61 fields · synced May 18, 2026
  • EUDAMED 33a42c02-8610-4c6a-947c-7e7864938b7e 61 fields · synced May 19, 2026