Identity
- Trade Name
- Portrait MMP01 EUDAMEDFDA UDI
- Generic Name
- Personal device holder, single-use FDA UDI
- Device Name
- Portrait Mobile Patient Monitor Pouch EUDAMEDPortrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS FDA UDI
- Model / Reference
- 5514246-30 EUDAMEDMMP01 FDA UDI
- Description
- Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS FDA UDI
Identifiers
- Catalog Number
- 5514246-30 FDA UDI
- Primary DI / UDI-DI
- 00195278699923 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00266HL EUDAMED
- 510(k) Number
- K230626 FDA UDI
- FDA Product Code
- BZQ FDA UDIDRG FDA UDIDQA FDA UDIMSX FDA UDIMWI FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Personal device holder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI870.2910 FDA UDI870.2700 FDA UDI870.2300 FDA UDI
- Market of Registration
- Finland 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose multi-parameter bedside monitor
Portrait MMP01 by GE Healthcare Finland Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 8406821BUG00266HL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED 5fd58393-673b-4939-9a36-604c30fdd1f7 61 fields · synced Oct 8, 2026
- FDA UDI aa9c809f-f224-4af1-9b9c-05b603077a76 36 fields · synced May 30, 2026