Identity
- Device Name
- VS Module EUDAMED
- Model / Reference
- SP-001-A-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50605506500518 EUDAMED
- Basic UDI-DI
- B-50605506500518 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
Category: Electrical-only medical device connection cable, reusable
VS Module by SurePulse Medical Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-50605506500518 | 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 d4bc300a-2757-49df-8903-94f72f4d74dc 61 fields · synced Jun 19, 2026