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Patient Monitor

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref iX10

by Edan Instruments, Inc.

Identity

Trade Name
Patient Monitor EUDAMEDFDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
Patient Monitor EUDAMED
Model / Reference
iX10 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
06944413815889 EUDAMEDFDA UDI
Basic UDI-DI
69444138iXS9L EUDAMED
FDA Product Code
MLD FDA UDI
MHX FDA UDI
CBS FDA UDI
CBQ FDA UDI
NHO FDA UDI
DPS FDA UDI
DSI FDA UDI
DRT FDA UDI
NHP FDA UDI
DXN FDA UDI
DSK FDA UDI
FLL FDA UDI
DQA FDA UDI
CBR FDA UDI
BZQ FDA UDI
CCL FDA UDI
NHQ FDA UDI
CCK 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 EUDAMED
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
868.1620 FDA UDI
868.1500 FDA UDI
870.2340 FDA UDI
870.2300 FDA UDI
870.1130 FDA UDI
870.1110 FDA UDI
880.2910 FDA UDI
870.2700 FDA UDI
868.1700 FDA UDI
868.2375 FDA UDI
868.1720 FDA UDI
868.1400 FDA UDI
Market of Registration
Germany 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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Patient Monitor by Edan Instruments, Inc. — Class IIb — 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

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Manufacturer

Manufacturer
Edan Instruments, Inc.
EUDAMED SRN
CN-MF-000009957
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED f011ec13-d6c8-403a-8d01-cbdea2a1158b 61 fields · synced Jul 20, 2026
  • FDA UDI c967c08e-4e22-4de1-97bb-c2efee017b3f 32 fields · synced May 30, 2026