uMEC12 Patient Monitor
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Patient Monitor EUDAMEDuMEC12 Patient Monitor FDA UDI
- Generic Name
- General-purpose multi-parameter bedside monitor FDA UDI
- Device Name
- Patient Monitor EUDAMED
- Model / Reference
- uMEC12 EUDAMEDFDA UDIuMEC6, uMEC15S, uMEC15, uMEC10, uMEC7, uMEC12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936415927448 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06936415927448 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- General-purpose multi-parameter bedside monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose multi-parameter bedside monitor
uMEC12 Patient Monitor by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (2)
- FDA UDI da0e69b7-7f4b-4e04-a8e0-5a69fd7461b5 32 fields · synced Oct 6, 2026
- EUDAMED 8a6190fc-c281-4487-9a24-e34ef71fffae 61 fields · synced Oct 6, 2026