Identity
- Trade Name
- E-musb FDA UDI
- Generic Name
- Patient monitoring system module, interfacing FDA UDI
- Device Name
- E-musb EUDAMEDE-musb MJU101, MODULE ASSEMBLY FDA UDI
- Model / Reference
- MJU101 EUDAMEDFDA UDIE-musb EUDAMED
- Description
- E-musb MJU101, MODULE ASSEMBLY FDA UDI
Identifiers
- Catalog Number
- E-musb FDA UDI
- Primary DI / UDI-DI
- 00840682145435 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682145435 EUDAMED8406821BUG00126H3 EUDAMED
- FDA Product Code
- QEM FDA UDIMUD FDA UDICCK FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Patient monitoring system module, interfacing FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI868.1400 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
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
E-musb by GE Healthcare Finland Oy — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840682145435 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | B-00840682145435 | 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 dede7583-040c-42e1-ba95-8161d8d39dca 61 fields · synced Oct 6, 2026
- EUDAMED 2378e518-37c1-4686-a6bb-13dd51079a14 61 fields · synced May 17, 2026
- FDA UDI 6d170773-2734-4b5d-af5f-126b350e34f8 36 fields · synced May 29, 2026