← Back to catalogue
PMD-200 Single Use Sensor
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref MEK-0002Model PMD200-2
Identity
- Trade Name
- PMD-200 Single Use Sensor EUDAMEDFDA UDI
- Generic Name
- Analgesia nociception index monitoring system FDA UDI
- Device Name
- PMD-200 Pain Monitoring System EUDAMED
- Model / Reference
- PMD200-2 EUDAMEDMEK-0002 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- MEK-0002 FDA UDI
- Primary DI / UDI-DI
- 07290017287201 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290017287PMD2003Z EUDAMED
- 510(k) Number
- DEN210022 FDA UDI
- FDA Product Code
- QVE FDA UDI
- EMDN Code
- Z12039085 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - CONSUMABLES EUDAMED
- GMDN Term
- Analgesia nociception index monitoring system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2200 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
PMD-200 Single Use Sensor by Medasense Biometrics Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN210022 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7290017287PMD2003Z | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medasense Biometrics Ltd.
- EUDAMED SRN
- IL-MF-000022765
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (3)
- EUDAMED f0a21e32-dab4-4fa5-8082-cf5f292aeb71 61 fields · synced Jun 19, 2026
- FDA UDI 4f6edeac-3fcc-413f-993b-a71896cd3cf8 36 fields · synced May 30, 2026
- FDA 510(k) DEN210022 1 fields · synced May 18, 2026