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MDoloris Medical Systems
EUDAMEDClass I (EU MDR)
Ref ART0076Model ANI Sensor V1 PLUSRef ART0074Model ANI Sensor V2Ref ART0216Model ANI-MR
Identity
- Trade Name
- MDoloris Medical Systems EUDAMED
- Device Name
- ANI Sensor V1 PLUS EUDAMEDANI Sensor V2 EUDAMEDANI-MR EUDAMED
- Model / Reference
- ANI Sensor V1 PLUS EUDAMEDART0076 EUDAMEDANI Sensor V2 EUDAMEDART0074 EUDAMEDANI-MR EUDAMEDART0216 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760232460313 EUDAMED03760232460207 EUDAMED03760232460399 EUDAMED
- Basic UDI-DI
- 376023246ANI-SENSV1PLUSEH EUDAMED376023246ANI-SENSV2GE EUDAMED376023246ANI-MR2X EUDAMED
- Direct Marketing DI
- 03760232460313 EUDAMED03760232460207 EUDAMED03760232460399 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMEDZ12050703 POLYGRAPHY SYSTEMS FOR ELECTROPHYSIOLOGICAL STUDIES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Belgium EUDAMEDFrance 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
Category: Electrocardiographic electrode, single-use
MDoloris Medical Systems by MDoloris Medical Systems SAS — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 376023246ANI-SENSV1PLUSEH | Class I | Active |
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Manufacturer
- Manufacturer
- MDoloris Medical Systems SAS
- EUDAMED SRN
- FR-MF-000000421
Sources (3)
- EUDAMED e01d2fc5-f121-4456-8579-42d02cc34dad 61 fields · synced Jul 27, 2026
- EUDAMED 1035edb5-2f13-4639-ae27-9a5aa7645104 61 fields · synced May 18, 2026
- EUDAMED 020954ba-a257-4720-aca5-de5bcb41179c 61 fields · synced Jul 9, 2026