Identity
- Trade Name
- Visensia V4.2.1.50 EUDAMED
- Device Name
- Visensia EUDAMED
- Model / Reference
- 011-0700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 5060457930102 EUDAMED
- Basic UDI-DI
- B-5060457930102 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Visensia V4.2.1.50 by OBS Medical Ltd — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081140 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-5060457930102 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OBS Medical Ltd
- EUDAMED SRN
- GB-MF-000028311
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (2)
- EUDAMED f249151f-66d6-4249-8f69-198c61b36be9 61 fields · synced Jun 19, 2026
- FDA 510(k) K081140 1 fields · synced May 18, 2026