Identity
- Trade Name
- Entropy FDA UDI
- Generic Name
- Analytical scalp lead FDA UDI
- Device Name
- GE Entropy Cable, 3,5 m EUDAMEDGE Entropy Cable EUDAMED
- Model / Reference
- M1050784 EUDAMEDEntropy Cable, M1050784 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682102964 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682102964 EUDAMED08406821BUG0052375 EUDAMED
- Direct Marketing DI
- 00840682102964 EUDAMED
- 510(k) Number
- K062580 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Analytical scalp lead FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Finland 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
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
MR Unsafe FDA UDI
GE Entropy Cable, 3, 5 m by GE Healthcare Finland Oy — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00840682102964 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00840682102964 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (3)
- EUDAMED bc6eab2d-5352-4425-9b4b-1fd05ab7109f 61 fields · synced Oct 6, 2026
- FDA UDI 4f946fbb-4535-40ec-9fba-b6bed34f666a 35 fields · synced May 30, 2026
- EUDAMED 772c195b-1e30-42ef-af80-c3b4427e7ba9 61 fields · synced Jul 15, 2026