← Back to catalogue
MY01 Mobile Application
EUDAMEDClass IIa (EU MDR)
Ref MY01-APPModel MY01-0001
by MY01 Inc.
Identity
- Trade Name
- MY01 Mobile Application EUDAMED
- Device Name
- MY01 Continuous Compartmental Pressure Monitor EUDAMED
- Model / Reference
- MY01-0001 EUDAMEDMY01-APP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540162030048 EUDAMED
- Basic UDI-DI
- 754016203000000000002SC EUDAMED
- EMDN Code
- Z12039002 INTRA COMPARTMENTAL PRESSURE MONITOR SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MY01 Mobile Application by MY01 Inc — 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 | 754016203000000000002SC | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MY01 Inc.
- EUDAMED SRN
- CA-MF-000002178
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED ee3fd11f-c6f9-43b3-ae02-b1e56d2310ff 61 fields · synced Jun 19, 2026