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EUDAMED Device Search

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

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ELECTRODE BOX

Electrode Box

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14086110
Basic UDI-DI: ++B140ElectrodeZ3
Reference: 8611
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

MediByte Software

MP-8

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B140200090
Basic UDI-DI: ++B140MediByte4Q
Reference: 2000
EMDN: Z12100582
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

Ultima Pressure Sensor Hydrophobic Filter

0583

Class IMDR 2017/745On the marketSingle use

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14005830
Basic UDI-DI: ++B140FilterJ2
Reference: 0583
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

Ultima Nasal Cannula + Filter

Airflow Cannula

Class IMDR 2017/745No longer on the marketSingle use

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14005820
Basic UDI-DI: ++B140CannulaPD
Reference: 0582
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

MediByte to CPAP Adapter

8552

Class IMDR 2017/745On the market

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14085520
Basic UDI-DI: ++B140TubingQ4
Reference: 8552
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: France
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:52

Manufacturer products Authorised representative products Authorised representative actors View details

ULTIMA PRESSURE SENSOR

0581

Class IMDR 2017/745On the marketDirect marking

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14005810
Basic UDI-DI: ++B140PressureS3
Reference: 0581
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Q-Snor interface

0546

Class IMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14005440
Basic UDI-DI: ++B140QSnorD6
Reference: 0544
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

ULTIMA SNORE MICROPHONE

0540

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14005400
Basic UDI-DI: ++B140Snoring56
Reference: 0540
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Ultima PVDF Respiratory Effort Sensor

Respiratory Effort Sensors

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14005200
Basic UDI-DI: ++B140EffortFU
Reference: 0520
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Ultima Airflow Sensor

0510

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14005100
Basic UDI-DI: ++B140AirflowRF
Reference: 0510
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

1/2 AA Li-Ion Rechargeable Batteries

0429

Class IMDR 2017/745On the marketActive device

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B140041221
Basic UDI-DI: ++B140BATTERIESYY
Reference: 0412-2
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Dual Keyhole Connector to 2 mm Male Safety Pin Connector Cable

Connector Cables

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14003500
Basic UDI-DI: ++B140ConnectSW
Reference: 0350
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Pneumo Flow Sensor

0310

Class IMDR 2017/745On the market

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14003100
Basic UDI-DI: ++B140FlowH7
Reference: 0310
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Paper Tape

0305

Class IMDR 2017/745On the marketSingle use

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14003050
Basic UDI-DI: ++B140TapeHH
Reference: 0305
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

Male to Male Luer Adapter

0303

Class IMDR 2017/745On the marketSingle use

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: B14003030
Basic UDI-DI: ++B140Connector4X
Reference: 0303
EMDN: Z12100585
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:51

Manufacturer products Authorised representative products Authorised representative actors View details

LZI Methadone Metabolite (EDDP) 100 Low Calibrator (50 ng/mL)

Methadone Metabolite Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: B0760202B0
Basic UDI-DI: ++B076CCEDDP01HT
Reference: 0202b
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

Ultima Body Position Sensor with 2.5 mm Phone Connector

0532

Class IMDR 2017/745No longer on the marketActive deviceDirect marking

Manufacturer: BRAEBON Medical Corporation
Manufacturer SRN: CA-MF-000002190
UDI-DI: ++B1400534TY
Basic UDI-DI: ++B140BodyPositionVB
Reference: 0534
EMDN: Z12100580
EMDN description: POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

++B379CHKGCZP

IVD generalNot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379CHKGCZP
Basic UDI-DI: B-++B379CHKGCZP
Reference: CHKG-C
EMDN: -
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

++B379CHKMC2C

IVD generalNot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379CHKMC2C
Basic UDI-DI: B-++B379CHKMC2C
Reference: CHKM-C
EMDN: -
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

++B379CL025TT

IVD generalNot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: InBios International, Inc.
Manufacturer SRN: US-MF-000020625
UDI-DI: ++B379CL025TT
Basic UDI-DI: B-++B379CL025TT
Reference: CL025
EMDN: -
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Ireland
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details