Apexpulse
by Apex (Guangzhou) Tools & Orthopedics Co. 9 variants
Ref 201-00-37
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-16957277200118 16957277200118 | Date15 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Shower Spray Tip with Splash Shield
- Model / Reference
- 201-00-37
- Primary DI / UDI-DI
- 16957277200118
- Basic UDI-DI
- B-16957277200118
- EMDN Code
- A0380 Tubular devices - accessories
- Device Class
- Class IIa
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000018403
- Authorised representative
- Wellkang Ltd XI-AR-000001836
Other devices from Apex (Guangzhou) Tools & Orthopedics Co.
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Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No