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MY01 Mobile Application
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MY01-APPModel MY01-0001
by MY01 Inc.
Identity
- Trade Name
- MY01 Mobile Application EUDAMEDFDA UDI
- Generic Name
- Compartmental-pressure monitoring system, single-use FDA UDI
- Device Name
- MY01 Continuous Compartmental Pressure Monitor EUDAMED
- Model / Reference
- MY01-0001 EUDAMEDMY01-APP EUDAMEDv1.22 FDA UDI
Identifiers
- Catalog Number
- MY01-APP FDA UDI
- Primary DI / UDI-DI
- 07540162030093 EUDAMEDFDA UDI
- Basic UDI-DI
- 754016203000000000002SC EUDAMED
- 510(k) Number
- K242997 FDA UDI
- FDA Product Code
- LXC FDA UDI
- EMDN Code
- Z12039002 INTRA COMPARTMENTAL PRESSURE MONITOR SYSTEMS EUDAMED
- GMDN Term
- Compartmental-pressure monitoring system, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MY01 Mobile Application by MY01 Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 754016203000000000002SC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MY01 Inc.
- EUDAMED SRN
- CA-MF-000002178
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 4a2c9f2d-e906-4fb8-a590-f1d906ee37d9 61 fields · synced Jul 17, 2026
- FDA UDI eb2efd20-e0d4-4793-be30-489122d5e849 34 fields · synced May 30, 2026