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Combi 4000 (a combination of tympanometry and rhinomanometry)

Combi 4000

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: G. Heinemann Medizintechnik GmbH
Manufacturer SRN: DE-MF-000009705
UDI-DI: 04260548935554
Basic UDI-DI: B-04260548935554
Reference: 80-1040
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:26

Manufacturer products View details

Tymp 4000 (Tympanometer)

Tymp 4000

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: G. Heinemann Medizintechnik GmbH
Manufacturer SRN: DE-MF-000009705
UDI-DI: 04260548935547
Basic UDI-DI: B-04260548935547
Reference: 80-1042
EMDN: Z12149005
EMDN description: IMPEDANCE METERS FOR THE AUDITORY SYSTEM
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:26

Manufacturer products View details

Combi 4000-M (a combination of tympanometry and rhinomanometry)

Combi 4000-M

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: G. Heinemann Medizintechnik GmbH
Manufacturer SRN: DE-MF-000009705
UDI-DI: 04260548935523
Basic UDI-DI: B-04260548935523
Reference: 80-1010
EMDN: Z12149099
EMDN description: VARIOUS ENT INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:26

Manufacturer products View details

Tymp 4000-M (Tympanometer)

Tymp 4000-M

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: G. Heinemann Medizintechnik GmbH
Manufacturer SRN: DE-MF-000009705
UDI-DI: 04260548935516
Basic UDI-DI: B-04260548935516
Reference: 80-1012
EMDN: Z12149005
EMDN description: IMPEDANCE METERS FOR THE AUDITORY SYSTEM
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:26

Manufacturer products View details

VARIO Dry

Class IIaMDDOn the marketActive device

Manufacturer: Happersberger otopront GmbH
Manufacturer SRN: DE-MF-000017407
UDI-DI: 04260154546304
Basic UDI-DI: B-04260154546304
Reference: 325401
EMDN: Z12149004
EMDN description: OTO-CALORIC STIMULATORS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:36

Manufacturer products View details

VARIO

Class IIaMDDOn the marketActive device

Manufacturer: Happersberger otopront GmbH
Manufacturer SRN: DE-MF-000017407
UDI-DI: 04260154546205
Basic UDI-DI: B-04260154546205
Reference: 325425
EMDN: Z12149004
EMDN description: OTO-CALORIC STIMULATORS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:35

Manufacturer products View details

RHINO-SYS

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: Happersberger otopront GmbH
Manufacturer SRN: DE-MF-000017407
UDI-DI: 04260154546045
Basic UDI-DI: B-04260154546045
Reference: 740011
EMDN: Z12149009
EMDN description: RHINOMETERS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 11:35

Manufacturer products View details

Varioair

Class IIaMDDOn the marketActive device

Manufacturer: ATMOS MedizinTechnik GmbH & Co. KG
Manufacturer SRN: DE-MF-000005570
UDI-DI: 04250365143065
Basic UDI-DI: B-04250365143065
Reference: 502.1100.0
EMDN: Z12149004
EMDN description: OTO-CALORIC STIMULATORS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 09:22

Manufacturer products View details

Variotherm plus

Class IIaMDDOn the marketActive device

Manufacturer: ATMOS MedizinTechnik GmbH & Co. KG
Manufacturer SRN: DE-MF-000005570
UDI-DI: 04250365142273
Basic UDI-DI: B-04250365142273
Reference: 502.0900.0
EMDN: Z12149004
EMDN description: OTO-CALORIC STIMULATORS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 09:22

Manufacturer products View details

PRO METAL DW

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Puma Srl
Manufacturer SRN: IT-MF-000047643
UDI-DI: 08057507851682
Basic UDI-DI: 805750785MDWZ12149002BM
Reference: PRO METAL DW
EMDN: Z12149002
EMDN description: AUDIOMETRIC CHAMBERS
First on market country: Italy
Authorised representative: -
Last updated: 04.08.2026 22:37

Manufacturer products View details

Soundproof Booth

TRA10, TRA15, TRA20, TRA25, TRA30,TRA35,TRA40,TRA45,TRA50,TRB10,TRB15,RB20,TRB25, TRB30, TRB35, TRB40, TRB45, TRB50, TRC10, TRC15, TRC20, TRC25, TRC30,TRC35,TRC40,TRC45,TRC50,TRD25, TRD30, TRD35, TRD40, TRD45,TRD50,TRE25,TRE30,TRE35,TRE40,TRE45,TRE50

Class IMDR 2017/745On the market

Manufacturer: Hangzhou Tingoton Technology Co.,Ltd
Manufacturer SRN: CN-MF-000042033
UDI-DI: 06976337770999
Basic UDI-DI: 697633777130P9
Reference: TRA10
EMDN: Z12149002
EMDN description: AUDIOMETRIC CHAMBERS
First on market country: Germany
Authorised representative: Humiss Beratung GmbH
Last updated: 04.08.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

ET-10

Ear Tips for Ear Probes

Class IMDR 2017/745On the marketSingle use

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223145339
Basic UDI-DI: 0426022Probes-16B
Reference: 100064-100
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 21:07

Manufacturer products View details

ET-03

Ear Tips for Ear Probes

Class IMDR 2017/745On the marketSingle use

Manufacturer: PATH MEDICAL GmbH
Manufacturer SRN: DE-MF-000006935
UDI-DI: 04260223145322
Basic UDI-DI: 0426022Probes-16B
Reference: 100063-100
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 20:58

Manufacturer products View details

Fiber Optic Otoscope (Pocket Style)

500-10

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: UAMED Surgical Industries
Manufacturer SRN: PK-MF-000029358
UDI-DI: ++G21550010
Basic UDI-DI: ++G21550010F8
Reference: 500-10
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: Yellow's medical instruments GmbH
Last updated: 03.08.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Fiber Optical Otoscope (Pocket Style)

500-20

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: UAMED Surgical Industries
Manufacturer SRN: PK-MF-000029358
UDI-DI: ++G21550020
Basic UDI-DI: ++G21550020FB
Reference: 500-20
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: Yellow's medical instruments GmbH
Last updated: 03.08.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

UAMEDFiber Optic (Metal Otoscope)

500-30

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: UAMED Surgical Industries
Manufacturer SRN: PK-MF-000029358
UDI-DI: ++G21550030
Basic UDI-DI: ++G21550030FE
Reference: 500-30
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: Yellow's medical instruments GmbH
Last updated: 03.08.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

UAMEDConventional (Plastic Head Otoscope)

500-40

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: UAMED Surgical Industries
Manufacturer SRN: PK-MF-000029358
UDI-DI: ++G21550040
Basic UDI-DI: ++G21550040FH
Reference: 500-40
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: Yellow's medical instruments GmbH
Last updated: 03.08.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

UAMED

500-60

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: UAMED Surgical Industries
Manufacturer SRN: PK-MF-000029358
UDI-DI: ++G21550060
Basic UDI-DI: ++G21550050FL
Reference: 500-60
EMDN: Z12149006
EMDN description: DIRECT OUTPATIENT OTOSCOPES
First on market country: Germany
Authorised representative: Yellow's medical instruments GmbH
Last updated: 03.08.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

Otodynamics

NOVA-SCR-DPTE

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: OTODYNAMICS LTD
Manufacturer SRN: GB-MF-000018964
UDI-DI: 05060396171574
Basic UDI-DI: B-05060396171574
Reference: NOVA-SCR-DPTE
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

Otodynamics

NOVA-SCR-DP

Class IIaMDDOn the marketActive deviceMeasuring function

Manufacturer: OTODYNAMICS LTD
Manufacturer SRN: GB-MF-000018964
UDI-DI: 05060396171550
Basic UDI-DI: B-05060396171550
Reference: NOVA-SCR-DP
EMDN: Z12149001
EMDN description: OTOACOUSTIC EMISSIONS EQUIPMENT
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details