Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

01.08.2026 16:25

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Device

2989605

Actor

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Certificate

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Active filter:EMDN:Z12011401

112 device results listed.

Page 2 / 6

IMACTIS Navigation station

IMACTIS® Navigation Station

Class IIbMDR 2017/745On the marketActive deviceDirect marking
Manufacturer
IMACTIS SAS
Manufacturer SRN
FR-MF-000004452
UDI-DI
+B681J0200000
Basic UDI-DI
++B6816000EMSW5
Reference
J02000
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
France
Authorised representative
-
Last updated
15.07.2026 14:56
Class IIaMDDOn the marketActive deviceReusable
Manufacturer
Ekliptik razvoj in svetovanje d.o.o.
Manufacturer SRN
SI-MF-000001172
UDI-DI
D-SI-MF-0000011729J
Basic UDI-DI
B-SI-MF-0000011729J
Reference
GSS04
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
Slovenia
Authorised representative
-
Last updated
15.07.2026 06:29
Perseus Device Sensor

Perseus Device Sensor

Class IMDDOn the marketActive deviceMeasuring functionSingle useSterile
Manufacturer
ORTHOKEY ITALIA SRL
Manufacturer SRN
IT-MF-000026488
UDI-DI
08052675960013
Basic UDI-DI
B-08052675960013
Reference
20100801
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
Italy
Authorised representative
-
Last updated
07.07.2026 19:40
Robin Navigation Unit

Robin Navigation

Class IIaMDR 2017/745On the marketActive device
Manufacturer
ORTHOKEY ITALIA SRL
Manufacturer SRN
IT-MF-000026488
UDI-DI
08052675961010
Basic UDI-DI
805267596Robin2U
Reference
20000102
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
Italy
Authorised representative
-
Last updated
03.07.2026 09:33
OTS™ Medizinisches elektrisches System

OTS Medical Electrical System

Class IMDR 2017/745On the marketActive device
Manufacturer
Ortoma AB
Manufacturer SRN
SE-MF-000034945
UDI-DI
07350137520890
Basic UDI-DI
735013752OTSMESHC
Reference
30-226
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
Sweden
Authorised representative
-
Last updated
03.07.2026 05:05
OTS™ Tracer IN

OTS Tracers

Class IMDR 2017/745On the marketSingle useSterile
Manufacturer
Ortoma AB
Manufacturer SRN
SE-MF-000034945
UDI-DI
07350137520111
Basic UDI-DI
735013752OTSTracersSP
Reference
30-151
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
Sweden
Authorised representative
-
Last updated
03.07.2026 05:05
Class IIbMDR 2017/745On the market
Manufacturer
Ortoma AB
Manufacturer SRN
SE-PR-000048670
UDI-DI
07350137520012
Basic UDI-DI
735013752OTSHipLY
Reference
30-101
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
-
Authorised representative
-
Last updated
03.07.2026 05:05
OTS™ Mandrin und Pin

OTS Reusable Instruments

Class IMDR 2017/745On the marketCMR substanceDirect markingReusable
Manufacturer
Ortoma AB
Manufacturer SRN
SE-MF-000034945
UDI-DI
07350137520036
Basic UDI-DI
735013752OTSInstrument39
Reference
30-117
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
Sweden
Authorised representative
-
Last updated
03.07.2026 05:05
OTS™ Hüftführungs-Software

OTS Hip Guide Software

Class IIbMDR 2017/745On the marketActive deviceMeasuring function
Manufacturer
Ortoma AB
Manufacturer SRN
SE-MF-000034945
UDI-DI
07350137520029
Basic UDI-DI
735013752OTSHipGuideQN
Reference
20-100
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
Sweden
Authorised representative
-
Last updated
03.07.2026 05:05
Dental Implant Navigation Equipment

Dental Implant Navigation Equipment

Class IIaMDR 2017/745On the marketActive deviceDirect marking
Manufacturer
Suzhou Digital-health Care Co. Ltd.
Manufacturer SRN
CN-MF-000035238
UDI-DI
06975155840280
Basic UDI-DI
697515584001LW
Reference
DHC-DI7
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
Germany
Authorised representative
MedPath GmbH
Last updated
02.07.2026 18:17
Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function
Manufacturer
Shenzhen Futurtec Medical Co.,LTD.
Manufacturer SRN
CN-MF-000034856
UDI-DI
06974385360025
Basic UDI-DI
697438536XGK-6508BK3
Reference
XGK-6508B
EMDN
Z12011401
EMDN description
SURGICAL NAVIGATION SYSTEM
First on market country
Northern Ireland
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
02.07.2026 15:56