Identity
- Trade Name
- OptiBP EUDAMED
- Device Name
- Optical blood pressure measurement EUDAMED
- Model / Reference
- 012.001.001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640255020977 EUDAMED07640255020618 EUDAMED
- Basic UDI-DI
- 764025502TD0123Y EUDAMED
- EMDN Code
- Z12030292 VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OptiBP by Effectum Medical AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764025502TD0123Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Effectum Medical AG
- EUDAMED SRN
- CH-MF-000012474
- Authorised Representative
- MED-RAS GmbH Regulatory Affairs Service DE-AR-000006211
Sources (2)
- EUDAMED f45e2f14-24ce-44ca-9f14-fb7461b0329a 61 fields · synced Oct 6, 2026
- EUDAMED 816d7c1b-e466-45cd-a1e7-271d80d6e7c3 61 fields · synced May 17, 2026