Identity
- Trade Name
- PMD-200 EUDAMED
- Device Name
- PMD-200 Pain Monitoring Device EUDAMEDPMD-200 Pain Monitoring System EUDAMED
- Model / Reference
- PMD200-2 EUDAMEDSYS-1FP-21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290017287232 EUDAMED
- Basic UDI-DI
- B-07290017287232 EUDAMED7290017287PMD2003Z EUDAMED
- Direct Marketing DI
- 07290017287232 EUDAMED
- EMDN Code
- Z12039080 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pmd-200 by Medasense Biometrics Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07290017287232 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07290017287232 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medasense Biometrics Ltd.
- EUDAMED SRN
- IL-MF-000022765
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 4014c0f4-46e7-41b4-8e69-e2d173fbaff2 61 fields · synced Jul 31, 2026
- EUDAMED f19ca972-f479-4b5a-8bc7-45ca65c66e41 61 fields · synced May 17, 2026