Identity
- Device Name
- Box x10 VS Cap Medium EUDAMED
- Model / Reference
- SP-128-A-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50605506501058 EUDAMED
- Basic UDI-DI
- B-50605506501058 EUDAMED
- EMDN Code
- Z12030299 VITAL SIGNS MONITORING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Box x10 VS Cap Medium by SurePulse Medical Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-50605506501058 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SurePulse Medical Ltd.
- EUDAMED SRN
- GB-MF-000002759
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 5e513298-7fd1-4750-a195-be095360600f 61 fields · synced Jun 18, 2026