← Back to catalogue

Eqtmhs013 Sat13

EUDAMEDFDA UDI

Class I (EU MDR)

Ref ARDSAT239008A

by Maquet SAS

Identity

Trade Name
EQTMHS013 SAT13 EUDAMED
Maquet Equipment FDA UDI
Generic Name
Medical monitor/light mount FDA UDI
Device Name
Maquet Equipment EUDAMED
EQTMHS013 SAT13 FDA UDI
Model / Reference
ARDSAT239008A EUDAMEDFDA UDI
Description
EQTMHS013 SAT13 FDA UDI

Identifiers

Primary DI / UDI-DI
03700712411886 EUDAMEDFDA UDI
Basic UDI-DI
3700712421267RG EUDAMED
Direct Marketing DI
03700712411886 EUDAMED
FDA Product Code
FXR FDA UDI
EMDN Code
Z12010799 SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER EUDAMED
GMDN Term
Medical monitor/light mount FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
878.4160 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
Not 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

Yes

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

Eqtmhs013 Sat13 by Maquet Sas — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Maquet SAS
EUDAMED SRN
FR-MF-000002926

Sources (2)

  • EUDAMED 5cdf318c-0eb2-428f-98d7-a3ac722ee47f 61 fields · synced Jul 18, 2026
  • FDA UDI 21cc098a-a5a5-4b71-871b-991a1ff0b75e 35 fields · synced May 30, 2026