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PATIENT MONITOR CABLE GE SOLAR (MARQUETTE) 11 pins
EUDAMEDFDA UDIClass I (EU MDR)
Ref PSO-MC05
by Sophysa
Identity
- Trade Name
- PATIENT MONITOR CABLE GE SOLAR (MARQUETTE) 11 pins EUDAMEDSOPHYSA FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- PATIENT MONITOR CABLE EUDAMEDPatient Monitor Cable GE Solar (Marquette) 11 pins FDA UDI
- Model / Reference
- PSO-MC05 EUDAMEDFDA UDI
- Description
- Patient Monitor Cable GE Solar (Marquette) 11 pins FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124130737 EUDAMEDFDA UDI
- Basic UDI-DI
- 376012413PSOMCX000BS EUDAMED
- 510(k) Number
- K062584 FDA UDI
- FDA Product Code
- GWM FDA UDI
- EMDN Code
- Z12039099 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Market of Registration
- France 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
PATIENT MONITOR CABLE GE SOLAR (MARQUETTE) 11 pins by Sophysa — Class I — 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 | 376012413PSOMCX000BS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (2)
- EUDAMED a7b0ef5a-cecb-465c-b475-11c380e5cbe1 61 fields · synced Jun 19, 2026
- FDA UDI e75f9ee6-eb5d-400e-b4c3-1657115727cd 34 fields · synced May 29, 2026